FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GILTECH PLUS HYDROGEL SKIN DRESSING
K Number: K992094
·
Decision Sep 17, 1999
Classifications
1
FEI Numbers
292
Registration Numbers
292
Same Product Code
28
Applicant Total
3
Review Days
88
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Basic Information
- Device Name
- GILTECH PLUS HYDROGEL SKIN DRESSING
- K Number
- K992094
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4022
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Giltech Plus, Inc.
- Date Received
- June 21, 1999
- Decision Date
- September 17, 1999
- Product Code
- NAE
- 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 |
|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | FDA class 1 | General, Plastic Surgery |
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