FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CMI VACUUM PUMP
K Number: K914552
·
Decision Sep 7, 1993
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
9
Applicant Total
4
Review Days
697
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Basic Information
- Device Name
- CMI VACUUM PUMP
- K Number
- K914552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4400
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Columbia Medical & Surgical, Inc.
- Date Received
- October 11, 1991
- Decision Date
- September 7, 1993
- Product Code
- HDA
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HDA | Forceps, Obstetrical | FDA class 2 | Obstetrics/Gynecology |
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