FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDDRAINS
K Number: K931607
·
Decision Aug 6, 1993
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
1
Applicant Total
4
Review Days
127
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Basic Information
- Device Name
- MEDDRAINS
- K Number
- K931607
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Armm, Inc.
- Date Received
- April 1, 1993
- Decision Date
- August 6, 1993
- Product Code
- GBN
- 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 |
|---|---|---|---|
| GBN | Catheter, Pediatric, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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