FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAIN/CHROMIC CATGUT
K Number: K994002
·
Decision Feb 4, 2000
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
29
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- PLAIN/CHROMIC CATGUT
- K Number
- K994002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trading Consultants and Distributors Intl., Inc.
- Date Received
- November 24, 1999
- Decision Date
- February 4, 2000
- Product Code
- GAL
- 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 |
|---|---|---|---|
| GAL | Suture, Absorbable, Natural | FDA class 2 | General, Plastic Surgery |
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