The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Ab Vacuum Extractor Silc-cup.
| Device ID | K841492 |
| 510k Number | K841492 |
| Device Name: | AB VACUUM EXTRACTOR SILC-CUP |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | MEDELA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-10 |
| Decision Date | 1984-05-07 |