510(k) K980490
- Device
- SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
- Applicant
- SAGE PRODUCTS, INC.
- 510(k) number
- K980490
- Product code
- MMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-24
- Date received
- 1998-02-09
- Regulation
- 880.5570
- Classification name
- Container, Sharps
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE FALKSTROM
- Address
- 815 Tek Dr. Crystal Lake IL US 60014 60014
FDA Registration Numbers#
- 3012421607
- 3009149661
- 3015821396
- 3006990472
- 3007703436
- 3007617202
- 3003756985
- 3013584693
- 2243072
- 2183416
- 3004748528
- 3016815268
- 3012630624
- 3021887565
- 3007165189
- 3015997711
- 3005739529
- 3010621964
- 3011881552
- 3015058854
- 2133713
- 1123137
- 3014579161
- 3007681502
- 1419823
- 3038613790
- 3013298431
- 2939821
- 3021742805
- 3013429260
- 3003120666
- 3025432964
- 3011198121
- 1417592
- 3044026004
- 3004425647
- 3013256960
- 1450743
- 3010221586
- 1416891
- 3043226252
- 3010666393
- 3021167963
- 3014774380
- 3014683120
- 3013557562
- 3027486076
- 3009963993
- 3010194621
- 3012237654
- 3011689956
- 1836161
- 3020460367
- 8040619
- 3006636962
- 3000186388
- 3007344957
- 3012104670
- 3044466317
- 3007187674
- 3042872962
- 3012494290
- 9613648
- 3015140199
- 3000682787
- 3003537565
- 3021014160
- 3012908140
- 3007097064
- 1423507
- 3010515547
- 3015222108
- 1423537
- 3029906631
- 3008688054
- 3010508078
- 3009109991
- 3014662855
- 3042943294
- 3014255019
Source Documents#
Other 510(k) Records For Product Code MMK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026-05-22 |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025-12-22 |
| K252637 | Community Containers (Flap and Daisy) | Keter Canada, Inc. | 2025-10-14 |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | 2025-10-14 |
| K231484 | PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. | 2023-09-14 |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | Ningbo Maxcon Medical Technology Co., Ltd. | 2023-06-16 |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) | Ningbo Maxcon Medical Technology Co., Ltd. | 2023-06-01 |
| K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty , Ltd. | 2022-06-22 |
| K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | 2021-11-17 |
| K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | 2021-09-14 |
| K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | 2021-08-06 |
| K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd. | 2020-11-12 |
| K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019-05-31 |
| K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | 2019-05-20 |
| K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019-01-03 |
Legacy Summary#
summary
FDA Review#
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