The following data is part of a premarket notification filed by Marshall Baby Products with the FDA for Comfort Plus Nipple Shields.
| Device ID | K935340 |
| 510k Number | K935340 |
| Device Name: | COMFORT PLUS NIPPLE SHIELDS |
| Classification | Shield, Nipple |
| Applicant | MARSHALL BABY PRODUCTS 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Jane A Ehrhard |
| Correspondent | Jane A Ehrhard MARSHALL BABY PRODUCTS 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-05 |
| Decision Date | 1994-01-21 |