The following data is part of a premarket notification filed by Kaweco Gmbh with the FDA for Luxmatic 12-15 Isc Portable Electric Breast Pump.
| Device ID | K971543 |
| 510k Number | K971543 |
| Device Name: | LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | KAWECO GMBH 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk KAWECO GMBH 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-09-18 |
| Summary: | summary |