FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
EPI-LOCK WOUND DRESSING
K Number: K926034
·
Decision Apr 20, 1993
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
80
Applicant Total
19
Review Days
140
Basic Information
- Device Name
- EPI-LOCK WOUND DRESSING
- K Number
- K926034
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CALGON VESTAL DIV.
- Date Received
- December 1, 1992
- Decision Date
- April 20, 1993
- Product Code
- MGP
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
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Other Clearances by CALGON VESTAL DIV.
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|---|---|---|---|
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| 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 |