The following data is part of a premarket notification filed by Columbia Medical & Surgical, Inc. with the FDA for Cmi Velvet Touch Vacuum Extractor.
| Device ID | K942725 |
| 510k Number | K942725 |
| Device Name: | CMI VELVET TOUCH VACUUM EXTRACTOR |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 1530 Redmond, OR 97756 |
| Contact | Beverlee Louvring |
| Correspondent | Beverlee Louvring COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 1530 Redmond, OR 97756 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-09 |
| Decision Date | 1995-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671202VT0 | K942725 | 000 |