FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS
K Number: K914077
·
Decision Dec 2, 1991
Classifications
1
FEI Numbers
801
Registration Numbers
801
Same Product Code
55
Applicant Total
3
Review Days
82
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Basic Information
- Device Name
- REPEL(TM) LITE CUT RESISTANT GLOVE LINERS
- K Number
- K914077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Depuy-Raynham
- Date Received
- September 11, 1991
- Decision Date
- December 2, 1991
- Product Code
- LYU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LYU | Accessory, Surgical Apparel | FDA class 1 | General, Plastic Surgery |
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