FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ISOPORE(TM) TAPE, MODIFICATION
K Number: K925384
·
Decision Apr 21, 1993
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
27
Review Days
177
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Basic Information
- Device Name
- ISOPORE(TM) TAPE, MODIFICATION
- K Number
- K925384
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lectec Corp.
- Date Received
- October 26, 1992
- Decision Date
- April 21, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
FDA 510(k)
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PARALLEL
FDA 510(k)
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·General Hospital
Other Clearances by Lectec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K950943 | ULTRA EASE | Mar 7, 1996 | 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 |
| K881871 | SPARE MS 700 TENS ELECTRODE | Jun 16, 1988 | Substantially Equivalent |