FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CMI E-Z FLO BULB P.N. 701
K Number: K932128
·
Decision Apr 7, 1994
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
1
Applicant Total
4
Review Days
339
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Basic Information
- Device Name
- CMI E-Z FLO BULB P.N. 701
- K Number
- K932128
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Columbia Medical & Surgical, Inc.
- Date Received
- May 3, 1993
- Decision Date
- April 7, 1994
- Product Code
- FFY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
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