FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORTEX(TM) WOUND DRESSING
K Number: K914314
·
Decision Oct 23, 1991
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
19
Review Days
27
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Basic Information
- Device Name
- FORTEX(TM) WOUND DRESSING
- K Number
- K914314
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Calgon Vestal Div.
- Date Received
- September 26, 1991
- Decision Date
- October 23, 1991
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Calgon Vestal Div.
| K Number | Device Name | ||
|---|---|---|---|
| K944494 | ALSA-KLENZ | Oct 19, 1994 | Substantially Equivalent |
| K944033 | BILL EVANS-KLENZ | Oct 7, 1994 | Substantially Equivalent |
| K942270 | SAF-GEL HYDRATING DERMAL WOUND DRESSING | Aug 4, 1994 | Substantially Equivalent |
| K931477 | AMERSE | Jun 17, 1994 | Substantially Equivalent |
| K931816 | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM | May 26, 1994 | Substantially Equivalent |
| K931342 | LPH | May 26, 1994 | Substantially Equivalent |
| K941163 | MON-KLENZ | May 18, 1994 | Substantially Equivalent |
| K931573 | VESPHENE II | May 16, 1994 | Substantially Equivalent |
| K932277 | LONZA FORMULATION R-82 | May 12, 1994 | Substantially Equivalent |
| K931599 | HYDRASORB STERILE DRESSING | Jul 8, 1993 | Substantially Equivalent |