FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K Number: K971597
·
Decision Jul 29, 1997
Classifications
1
FEI Numbers
292
Registration Numbers
292
Same Product Code
28
Applicant Total
54
Review Days
89
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Basic Information
- Device Name
- COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
- K Number
- K971597
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4022
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- May 1, 1997
- Decision Date
- July 29, 1997
- 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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