FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇽 Mexico
SURGICAL CLOTH TAPE (HEALRITE)
K Number: K914596
·
Decision Mar 19, 1992
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
3
Review Days
155
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Basic Information
- Device Name
- SURGICAL CLOTH TAPE (HEALRITE)
- K Number
- K914596
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Industrias Tuk, S.A. DE C.V.
- Date Received
- October 16, 1991
- Decision Date
- March 19, 1992
- 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 |
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