FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TENDERM TAPE
K Number: K863194
·
Decision Sep 30, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
27
Review Days
42
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Basic Information
- Device Name
- TENDERM TAPE
- K Number
- K863194
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Lectec Corp.
- Date Received
- August 19, 1986
- Decision Date
- September 30, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Lectec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K950943 | ULTRA EASE | Mar 7, 1996 | Substantially Equivalent |
| K925384 | ISOPORE(TM) TAPE, MODIFICATION | Apr 21, 1993 | Substantially Equivalent |
| K930258 | TRACET T-6000 | Apr 16, 1993 | Substantially Equivalent |
| K923558 | ECG ELECTRODE | Feb 18, 1993 | Substantially Equivalent |
| K922959 | ISOPORE TAPE | Sep 11, 1992 | Substantially Equivalent |
| K912450 | TRACETS SME 5000 | Aug 28, 1991 | Substantially Equivalent |
| K904512 | TRACET AG 4000 | Jan 31, 1991 | Substantially Equivalent |
| K893425 | VITATRACE | Jul 14, 1989 | Substantially Equivalent |
| K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE | Nov 10, 1988 | Substantially Equivalent for Some Indications |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | Jul 20, 1988 | Substantially Equivalent |