FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
K Number: K861456
·
Decision Jul 25, 1986
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
16
Applicant Total
1
Review Days
98
Basic Information
- Device Name
- SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
- K Number
- K861456
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4440
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Pantheon Products, Inc.
- Date Received
- April 18, 1986
- Decision Date
- July 25, 1986
- Product Code
- HMP
- 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 |
|---|---|---|---|
| HMP | Pad, Eye | FDA class 1 | General, Plastic Surgery |
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