510(k) K932128
K932128 is an FDA 510(k) premarket notification submitted by Columbia Medical & Surgical, Inc. for the device "CMI E-Z FLO BULB P.N. 701". The FDA issued a decision of Substantially Equivalent on April 7, 1994. The device falls under product code FFY (Adaptor, Bulbs, Miscellaneous, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Columbia Medical & Surgical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1994
- Date Received
- May 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Bulbs, Miscellaneous, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type