The following data is part of a premarket notification filed by Columbia Medical & Surgical, Inc. with the FDA for Modified Disposable Fetal Vacuum.
| Device ID | K915763 |
| 510k Number | K915763 |
| Device Name: | MODIFIED DISPOSABLE FETAL VACUUM |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 5877 Bend, OR 97708 |
| Contact | Beverlee Louring |
| Correspondent | Beverlee Louring COLUMBIA MEDICAL & SURGICAL, INC. P.O. BOX 5877 Bend, OR 97708 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-03-18 |