510(k) K790654
- Device
- CLOSED WOUND VACUUM DRAINAGE SYSTEM
- Applicant
- 3M COMPANY
- 510(k) number
- K790654
- Product code
- GCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-04-26
- Date received
- 1979-04-05
- Regulation
- 878.4680
- Classification name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 8124 Pacific Ave. White City OR US 97503 97503
FDA Registration Numbers#
- 3013545943
- 3010131137
- 3010626066
- 8010939
- 3003399181
- 3000247987
- 9616088
- 3009051471
- 1061124
- 3016248634
- 9611590
- 3010373530
- 3013188547
- 8044057
- 1818910
- 3002806603
- 2528981
- 3013496867
- 3010757045
- 3011554160
- 3030447506
- 2020550
- 3014637079
- 3011137372
- 3010419931
- 3010202439
- 3016674858
- 3010621964
- 3021970868
- 3006673317
- 3010198939
- 3015058854
- 3003887292
- 3007329020
- 1123137
- 2648727
- 3009889060
- 1222928
- 3009171220
- 3013000203
- 3008264111
- 3002808270
- 8043323
- 1825034
- 3005176727
- 3018762668
- 3011743372
- 3008285983
- 3012316249
- 3026986849
- 2011171
- 3027847726
- 3005031124
- 1034117
- 3005720829
- 8030107
- 3010400865
- 3014827316
- 3016171914
- 3014342658
- 2027062
- 3012684779
- 9614062
- 2184009
- 1416980
- 8010730
- 1417592
- 3017618673
- 9610632
- 3003955307
- 3007007790
- 3010806410
- 1526350
- 3014926389
- 3026630
- 3013025177
- 3015276780
- 3017618900
- 3010325720
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972703 | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | 1997-10-01 |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | 1997-06-03 |
| K963839 | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | 1996-12-12 |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | 1996-03-11 |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | 1995-04-25 |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | 1994-05-12 |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | 1994-02-22 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | 1993-10-05 |
| K933306 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | 1993-10-05 |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | 1993-09-16 |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | 1993-08-11 |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | 1993-08-10 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | 1993-05-21 |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1993-05-17 |
Legacy Summary#
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FDA Review#
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