The following data is part of a premarket notification filed by Columbia Medical & Surgical, Inc. with the FDA for Cmi Vacuum Pump.
Device ID | K914552 |
510k Number | K914552 |
Device Name: | CMI VACUUM PUMP |
Classification | Forceps, Obstetrical |
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 | HDA |
CFR Regulation Number | 884.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-11 |
Decision Date | 1993-09-07 |