FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIFELINER SURGICAL GLOVE
K Number: K910941
·
Decision May 9, 1991
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
6
Applicant Total
3
Review Days
64
Basic Information
- Device Name
- LIFELINER SURGICAL GLOVE
- K Number
- K910941
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Depuy-Raynham
- Date Received
- March 6, 1991
- Decision Date
- May 9, 1991
- Product Code
- FYE
- 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 |
|---|---|---|---|
| FYE | Dress, Surgical | FDA class 1 | General, Plastic Surgery |
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