The following data is part of a premarket notification filed by Prolac, Inc. with the FDA for Breast Leakage Inhibitor System: Breast Shields.
| Device ID | K930238 |
| 510k Number | K930238 |
| Device Name: | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS |
| Classification | Shield, Nipple |
| Applicant | PROLAC, INC. 3 LAKE VIEW CIRCLE Skaneateles, NY 13152 |
| Contact | Gerald R Morrissey |
| Correspondent | Gerald R Morrissey PROLAC, INC. 3 LAKE VIEW CIRCLE Skaneateles, NY 13152 |
| Product Code | HFS |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-19 |
| Decision Date | 1993-08-16 |