FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇦 Saudi Arabia
UNICRYL
K Number: K042288
·
Decision Dec 27, 2004
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
10
Review Days
125
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Basic Information
- Device Name
- UNICRYL
- K Number
- K042288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- United Medical Industries Co. , Ltd.
- Date Received
- August 24, 2004
- Decision Date
- December 27, 2004
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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Other Clearances by United Medical Industries Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K072646 | UNICAPRONE | Nov 7, 2007 | Substantially Equivalent |
| K072644 | UNICRYL QUICK | Nov 7, 2007 | Substantially Equivalent |
| K072645 | UNIGLACTIN | Nov 7, 2007 | Substantially Equivalent |
| K042287 | UNIPLAIN & UNICHROM | Sep 7, 2005 | Substantially Equivalent |
| K042285 | UNICRYL M | Dec 10, 2004 | Substantially Equivalent |
| K042284 | UNIMIDE | Dec 3, 2004 | Substantially Equivalent |
| K042286 | UNIESTER C | Dec 1, 2004 | Substantially Equivalent |
| K042283 | UNIPRO | Dec 1, 2004 | Substantially Equivalent |
| K042282 | UNISILK | Dec 1, 2004 | Substantially Equivalent |