The following data is part of a premarket notification filed by Columbia Medical & Surgical, Inc. with the FDA for Cmi E-z Flo Bulb P.n. 701.
| Device ID | K932128 |
| 510k Number | K932128 |
| Device Name: | CMI E-Z FLO BULB P.N. 701 |
| Classification | Adaptor, Bulbs, Miscellaneous, For Endoscope |
| Applicant | COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 5877 Bend, OR 97708 |
| Contact | Beverlee Louvring |
| Correspondent | Beverlee Louvring COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 5877 Bend, OR 97708 |
| Product Code | FFY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-03 |
| Decision Date | 1994-04-07 |