FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DERMIZIP SKIN CLOSURE DEVICE
K Number: K844072
·
Decision Nov 5, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
18
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Basic Information
- Device Name
- DERMIZIP SKIN CLOSURE DEVICE
- K Number
- K844072
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- October 18, 1984
- Decision Date
- November 5, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K844463 | DERMIDRESS | Jan 8, 1985 | Substantially Equivalent |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Mar 7, 1984 | Substantially Equivalent |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Sep 29, 1983 | Substantially Equivalent |
| K823118 | SAY | Jan 7, 1983 | Substantially Equivalent |
| K823226 | SN-100 DOCTOR'S ROUND | Nov 22, 1982 | Substantially Equivalent |