The following data is part of a premarket notification filed by Schuco, Inc. with the FDA for Electric Powered Breast Pump.
| Device ID | K921261 |
| 510k Number | K921261 |
| Device Name: | ELECTRIC POWERED BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | SCHUCO, INC. 1419 EXPRESSWAY DRIVE NORTH Toledo, OH 43608 |
| Contact | Ralph Spang |
| Correspondent | Ralph Spang SCHUCO, INC. 1419 EXPRESSWAY DRIVE NORTH Toledo, OH 43608 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-16 |
| Decision Date | 1993-11-09 |