510(k) K880650
- Device
- HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
- Applicant
- Baxter Healthcare Corp
- 510(k) number
- K880650
- Product code
- GCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-24
- Date received
- 1988-02-17
- 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#
- Contact
- PETER SPARACIO
- Address
- 7280 N. Caldwell Niles IL US 60648 60648
FDA Registration Numbers#
- 3014827316
- 3017101761
- 3010041511
- 3011707784
- 3005206084
- 3020306752
- 2020550
- 3010419931
- 3010387558
- 3006581122
- 3013188547
- 1450395
- 9613558
- 1644312
- 9614062
- 1061771
- 3038141559
- 1123137
- 3010202439
- 3006082230
- 1921846
- 3005176727
- 3018762668
- 3009124884
- 9610632
- 3013025177
- 1034117
- 1019003
- 3003399181
- 3013517171
- 3003361112
- 2244478
- 1423537
- 3009104075
- 3006897996
- 3009494725
- 3002707546
- 3005720829
- 8030107
- 3000247987
- 3017385563
- 3012316249
- 3002807090
- 1223925
- 3012684779
- 2011171
- 3003418325
- 1018233
- 2084346
- 1937141
- 3015495690
- 2650143
- 3007838093
- 1314417
- 3005273623
- 1643817
- 3021244152
- 3011743372
- 3002806603
- 3010806410
- 1058584
- 3008791328
- 3010198939
- 3026630
- 3009495876
- 3041276591
- 3005031124
- 1061124
- 8010939
- 3015276780
- 3008191511
- 1424785
- 3005327291
- 1043214
- 2028175
- 3006210673
- 3017540705
- 9616088
- 3013909820
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
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| 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 |