FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TARGETT PATCH
K Number: K952606
·
Decision Dec 21, 1995
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
2
Review Days
198
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Basic Information
- Device Name
- TARGETT PATCH
- K Number
- K952606
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cutting Edge Technologies, Inc.
- Date Received
- June 6, 1995
- Decision Date
- December 21, 1995
- 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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CARE BAND ANTIBACTERIAL BANDAGES
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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PARALLEL
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DERMIVIEW HYPOALLERGENIC CLEAR TAPE
FDA 510(k)
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Other Clearances by Cutting Edge Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963595 | SERAGARD VASCULAR ACCESS DEVICE | Jan 6, 1997 | Substantially Equivalent |