FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
K Number: K962545
·
Decision Mar 7, 1997
Classifications
1
FEI Numbers
265
Registration Numbers
265
Same Product Code
270
Applicant Total
1
Review Days
252
Basic Information
- Device Name
- DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
- K Number
- K962545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- STERILIZATION CASSETTE SYSTEMS, INC.
- Date Received
- June 28, 1996
- Decision Date
- March 7, 1997
- Product Code
- KCT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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