The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Single Use Silc Cup, Model 077.0791.
| Device ID | K041579 |
| 510k Number | K041579 |
| Device Name: | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Werner Frei |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2005-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612367009355 | K041579 | 000 |