FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POST SURGICAL KIT/POST BIOPSY KIT
K Number: K910011
·
Decision Mar 27, 1991
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
23
Applicant Total
1
Review Days
84
Basic Information
- Device Name
- POST SURGICAL KIT/POST BIOPSY KIT
- K Number
- K910011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- DERMATOLOGICAL RESEARCH LABORATORIES, INC.
- Date Received
- January 2, 1991
- Decision Date
- March 27, 1991
- Product Code
- MCY
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
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