FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
E-Z DERM BIOSYNTHETIC WOUND DRESSING
K Number: K935189
·
Decision Jul 11, 1994
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
17
Review Days
258
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Basic Information
- Device Name
- E-Z DERM BIOSYNTHETIC WOUND DRESSING
- K Number
- K935189
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Brennen Medical, Inc.
- Date Received
- October 26, 1993
- Decision Date
- July 11, 1994
- Product Code
- KGN
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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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 |