FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYESTER
K Number: K994000
·
Decision Feb 4, 2000
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- POLYESTER
- K Number
- K994000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- 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
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Trading Consultants and Distributors Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994001 | POLYGLYCOLIC ACID | Feb 9, 2000 | Substantially Equivalent |
| K993999 | SILK | Feb 4, 2000 | Substantially Equivalent |
| K993998 | NYLON | Feb 4, 2000 | Substantially Equivalent |
| K994002 | PLAIN/CHROMIC CATGUT | Feb 4, 2000 | Substantially Equivalent |
| K993997 | POLYPROPYLENE | Feb 4, 2000 | Substantially Equivalent |