510(k) K091690

Device: SHARP CHUTE
Applicant: HEATHROW SCIENTIFIC, LLC
510(k) number: K091690
Product code: MMK
Decision: Substantially Equivalent (SESE)
Decision date: 2009-07-28
Date received: 2009-06-10
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: Yes

Related Records

Applicant Contact

Contact: PETE HADJIS
Address: 620 Lakeview Pkwy. Vernon Hills IL US 60061 60061

FDA Registration Numbers

3011881552
1423537
3006990472
3003674698
3012908140
3007165189
3038613790
3009109991
3000186388
3025432964
3015222108
2183771
3015997711
3021014160
8040619
3000682787
3014662855
3010194621
3021167963
3007703436
3042872962
3010508078
1423507
3011198121
3009963993
3021887565
3007508552
2032810
3012237654
2183416
1921846
3006636962
3010515547
1123137
3005739529
1450743
2243072
3007344957
3044466317
3010221586
1419823
3008688054
3021742805
3043226252
3003965134
3038356900
3015821396
3006670775
3008824562
3004425647
3003537565
1836161
3004748528
3007187674
3027486076
3015140199
3012104670
3013298431
3012630624
1416891
3029906631
3007681502
1417592
3015058854
3010666393
3009149661
3016548959
3007097064
3003756985
3007617202
3016761372
3012494290
3013256960
2939821
9613648
3018503755
3042943294
3014774380
3014255019

Source Documents

510(k) summary PDF

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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