FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FINGGUARD
K Number: K915056
·
Decision Feb 3, 1992
Classifications
1
FEI Numbers
801
Registration Numbers
801
Same Product Code
55
Applicant Total
2
Review Days
87
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Basic Information
- Device Name
- FINGGUARD
- K Number
- K915056
- 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
- Allied Signal, Inc.
- Date Received
- November 8, 1991
- Decision Date
- February 3, 1992
- 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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Other Clearances by Allied Signal, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884417 | SURGEON'S GLOVE ACCESSORY | Dec 9, 1988 | Substantially Equivalent |