FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD CONTAINMENT PACK
K Number: K872448
·
Decision Nov 17, 1987
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
19
Review Days
147
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Basic Information
- Device Name
- BLOOD CONTAINMENT PACK
- K Number
- K872448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Services
- Date Received
- June 23, 1987
- Decision Date
- November 17, 1987
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Professional Medical Services
| K Number | Device Name | ||
|---|---|---|---|
| K913094 | DISPOSABLE SLIDE VALVE MANIFOLD | Jan 27, 1992 | Substantially Equivalent |
| K910378 | PRESSURE MONITORING EXTENSION LINE | Apr 22, 1991 | Substantially Equivalent |
| K904508 | CONDOR ANALOG INFLATION SYRINGE | Apr 2, 1991 | Substantially Equivalent |
| K904954 | CONDOR DIGITAL INFLATION SYRINGE | Jan 16, 1991 | Substantially Equivalent |
| K902606 | RADIOPAQUE RULER | Sep 27, 1990 | Substantially Equivalent |
| K884577 | PROCEDURE READY TRAYS | Aug 1, 1989 | Unknown |
| K890471 | PMS ANGIO DRAPE | Feb 27, 1989 | Substantially Equivalent |
| K884497 | CONTROL SYRINGE | Dec 12, 1988 | Substantially Equivalent |
| K864555 | 3 RING ATTACHMENT | Dec 1, 1986 | Substantially Equivalent |
| K854941 | PMS PERCUTANEOUS PUNCTURE NEEDLE | Apr 16, 1986 | Substantially Equivalent |