FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOVAGEL SILICONE GEL SHEETING
K Number: K941125
·
Decision May 31, 1994
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
17
Review Days
83
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Basic Information
- Device Name
- NOVAGEL SILICONE GEL SHEETING
- K Number
- K941125
- 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
- Brennen Medical, Inc.
- Date Received
- March 9, 1994
- Decision Date
- May 31, 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 |
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Other Clearances by Brennen Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING | Feb 17, 2006 | Substantially Equivalent |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Mar 7, 2003 | Substantially Equivalent |
| K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | Oct 17, 2002 | Substantially Equivalent |
| K002078 | BETA GLUCAN GEL (MACROPRO GEL) | Oct 2, 2000 | Substantially Equivalent |
| K002077 | GLUCANPRO CREAM | Oct 2, 2000 | Substantially Equivalent |
| K000518 | MACROPRO GEL | May 1, 2000 | Substantially Equivalent |
| K000519 | GLUCANPRO | May 1, 2000 | Substantially Equivalent |
| K982825 | BRENNEN MEDICAL BETA GLUCAN GEL | Nov 6, 1998 | Substantially Equivalent |
| K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Sep 22, 1998 | Substantially Equivalent |
| K980962 | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO | Jul 29, 1998 | Substantially Equivalent |