FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DERMIVIEW CLEAR TAPE
K Number: K942383
·
Decision Aug 22, 1994
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
10
Review Days
95
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Basic Information
- Device Name
- DERMIVIEW CLEAR TAPE
- K Number
- K942383
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johnson & Johnson International
- Date Received
- May 19, 1994
- Decision Date
- August 22, 1994
- Product Code
- KGX
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
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|---|---|---|---|
| K965198 | ULTIMA TPS CEMENTED STEM | Jul 23, 1997 | Substantially Equivalent |
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| K946245 | TIELLE* HYDROPOLYMER DRESSING | Apr 11, 1995 | Substantially Equivalent |
| K922918 | BARRIER SAF-TE HYDROGEL DRAPE | Jul 6, 1993 | Substantially Equivalent |
| K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS | Nov 9, 1992 | Substantially Equivalent |
| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | Nov 21, 1990 | Substantially Equivalent |
| K901456 | ORTHOSORB(R) ABSORBABLE PIN | Aug 15, 1990 | Substantially Equivalent |
| K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT | Apr 30, 1990 | Substantially Equivalent |
| K895207 | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM | Sep 28, 1989 | Substantially Equivalent |