FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL INSTRUMENT KIT, DISPOSABLE
K Number: K893814
·
Decision Aug 10, 1989
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
10
Review Days
79
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Basic Information
- Device Name
- SURGICAL INSTRUMENT KIT, DISPOSABLE
- K Number
- K893814
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Bioseal
- Date Received
- May 23, 1989
- Decision Date
- August 10, 1989
- 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 Bioseal
| K Number | Device Name | ||
|---|---|---|---|
| K882695 | RUBBER BAND, STERILE | Oct 13, 1988 | Substantially Equivalent |
| K882696 | DERMICEL, MONTGOMERY STRAP | Aug 26, 1988 | Substantially Equivalent |
| K882694 | FIXATION DEVICE, TRACH TUBE | Aug 15, 1988 | Substantially Equivalent |
| K882710 | INTESTINAL SPONGES | Aug 3, 1988 | Substantially Equivalent |
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE | Aug 3, 1988 | Substantially Equivalent |
| K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING | Aug 3, 1988 | Substantially Equivalent |
| K882707 | GAUZE PACKING, X-RAY DETECTABLE | Aug 3, 1988 | Substantially Equivalent |
| K882711 | GAUZE SPONGE 12PLY | Aug 3, 1988 | Substantially Equivalent |
| K882712 | STICK SPONGE | Aug 3, 1988 | Substantially Equivalent |