FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DERM-A-TEC SKIN BARRIER FILM
K Number: K822713
·
Decision Dec 7, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
91
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Basic Information
- Device Name
- DERM-A-TEC SKIN BARRIER FILM
- K Number
- K822713
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Products, Inc.
- Date Received
- September 7, 1982
- Decision Date
- December 7, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | Feb 17, 1994 | Substantially Equivalent |
| K920292 | VARIOUS KITS AND TRAYS | Jan 26, 1994 | Unknown |
| K862010 | CHICK SURGICAL LIGHT | Jun 9, 1986 | Substantially Equivalent |
| K860739 | CHICK SURIGICAL LIGHT | Mar 28, 1986 | Substantially Equivalent |
| K834478 | CHICK/REISON PATIENT EMERG. TROLLEY | Feb 21, 1984 | Substantially Equivalent |
| K830825 | YIELD NON-ADHERENT DRESSING | May 13, 1983 | Substantially Equivalent |
| K820413 | AEGIS NON-ADHERENT DRESSING | Mar 12, 1982 | Substantially Equivalent |