FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DACRON R SURGICAL SUTURES
K Number: K904263
·
Decision Oct 16, 1990
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
16
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- DACRON R SURGICAL SUTURES
- K Number
- K904263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sharppoint, Inc.
- Date Received
- September 17, 1990
- Decision Date
- October 16, 1990
- Product Code
- GAS
- 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 |
|---|---|---|---|
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | FDA class 2 | General, Plastic Surgery |
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