FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILK*SKIN SCAR TREATMENT
K Number: K941197
·
Decision Aug 11, 1994
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
24
Review Days
150
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Basic Information
- Device Name
- SILK*SKIN SCAR TREATMENT
- K Number
- K941197
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Puritas Health Care, Inc.
- Date Received
- March 14, 1994
- Decision Date
- August 11, 1994
- Product Code
- MDA
- 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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Puritas Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942339 | SKIN NEUVEAU SCAR TREATMENT | Nov 28, 1994 | Substantially Equivalent |
| K935600 | TRACHEAL SUCTION CATHETER | May 10, 1994 | Unknown |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | May 5, 1994 | Substantially Equivalent |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Apr 21, 1994 | Substantially Equivalent |
| K940055 | MULTISET | Apr 15, 1994 | Substantially Equivalent |
| K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET | Apr 15, 1994 | Substantially Equivalent |
| K935583 | SUCTION SET, TRACHAEL | Apr 11, 1994 | Unknown |
| K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM | Apr 4, 1994 | Substantially Equivalent |
| K935532 | TRANSFER SET | Apr 4, 1994 | Substantially Equivalent |
| K940070 | STOPCOCK INTRAVENOUS THERAPY | Apr 4, 1994 | Substantially Equivalent |