REDYROB-CLOSED WOUND DRAINAGE SYSTEM
FDA 510(k) clearance K972703 · decided 1997-10-01
Clearance details
- K-number
- K972703
- Device name
- REDYROB-CLOSED WOUND DRAINAGE SYSTEM
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-18
- Decision date
- 1997-10-01
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- GCY
- Device class
- 1
- Regulation number
- 878.4680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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| AUTOVAC CLOSED WOUND SUCTION SYSTEM (K930615) | Boehringer Laboratories | 1994-02-22 |
| BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319) | Birtcher Medical Systems, Inc. | 1993-10-27 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE (K933305) | Inman Medical Corp. | 1993-10-05 |
| IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (K933306) | Inman Medical Corp. | 1993-10-05 |
| INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (K933170) | Inman Medical Corp. | 1993-09-16 |
| POOLE TIP SUCTION PROBE (K931950) | Mayaguez Medical Center | 1993-08-11 |
| 5.0 MM IRRIGATION/ASPIRATION PROBE (K931856) | Mayaguez Medical Center | 1993-08-10 |
Recalls involving this device
No recalls on record reference this clearance.