510(k) K802214
- Device
- COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM
- Applicant
- COX-UPHUFF INTL.
- 510(k) number
- K802214
- Product code
- GCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-23
- Date received
- 1980-09-12
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2184009
- 1417592
- 3007092328
- 8030107
- 9616354
- 3015495690
- 1530881
- 9612030
- 8022978
- 3012568936
- 1314417
- 3010387558
- 2029275
- 3004111573
- 3010041511
- 3017618673
- 3009134882
- 1644312
- 1820334
- 9611274
- 3013058659
- 3016159368
- 3021970868
- 3017540705
- 3005206084
- 3018116884
- 3008285983
- 1416980
- 3018762668
- 1643817
- 3010626066
- 1836161
- 1223925
- 3017618900
- 3014342658
- 1450662
- 3006897996
- 3041276591
- 3005012805
- 3010198939
- 9617601
- 3033435481
- 3008711096
- 3043226252
- 3013545943
- 3010160370
- 3010287621
- 3010373530
- 3016248634
- 1825034
- 3010806410
- 1123137
- 3007728072
- 3012711663
- 3012684779
- 3043648115
- 3020306752
- 3007360714
- 3010202439
- 1018233
- 9610612
- 3003887292
- 1034117
- 1424785
- 2020735
- 3038141559
- 3007123908
- 3026630
- 9616088
- 3016994953
- 3026986849
- 3005176727
- 2182291
- 1450395
- 8010730
- 3005031124
- 8044057
- 3007007790
- 3011137372
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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