The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Cannon Babysafe Nipple Shields.
| Device ID | K853176 |
| 510k Number | K853176 |
| Device Name: | CANNON BABYSAFE NIPPLE SHIELDS |
| Classification | Shield, Nipple |
| Applicant | MEDELA, INC. 6711 SANDS RD. Crystal Lake, IL 60014 |
| Contact | Gotthilf Weniger |
| Correspondent | Gotthilf Weniger MEDELA, INC. 6711 SANDS RD. Crystal Lake, IL 60014 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-12 |
| Decision Date | 1985-08-22 |