FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLEANSING AGENT, NEW WOUND (DEBRISSU)
K Number: K760469
·
Decision Dec 16, 1976
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
21
Applicant Total
5
Review Days
119
Basic Information
- Device Name
- CLEANSING AGENT, NEW WOUND (DEBRISSU)
- K Number
- K760469
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- PHARMASEAL LABORATORIES
- Date Received
- August 19, 1976
- Decision Date
- December 16, 1976
- Product Code
- KOZ
- 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 |
|---|---|---|---|
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | FDA class 1 | General, Plastic Surgery |
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