FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SURGI-WIPES
K Number: K863278
·
Decision Sep 2, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
8
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Basic Information
- Device Name
- SURGI-WIPES
- K Number
- K863278
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Dermacare Products, Inc.
- Date Received
- August 25, 1986
- Decision Date
- September 2, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Dermacare Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882494 | ELAN-E DISPOSALBE DRAPE | Jul 8, 1988 | Substantially Equivalent |
| K882421 | INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE | Jun 30, 1988 | Substantially Equivalent |
| K871910 | SURGITEK DISPOSABLE BIPOLAR CORD | Jun 1, 1987 | Substantially Equivalent |
| K863279 | SURGI-TEK TUBE POSITIONER | Sep 9, 1986 | Substantially Equivalent |
| K863280 | DERMAMARKER | Sep 9, 1986 | Substantially Equivalent |
| K862367 | PRO-CLEAN | Jul 8, 1986 | Substantially Equivalent |
| K853374 | CORRECT-A-COUNT | Sep 5, 1985 | Substantially Equivalent |