The following data is part of a premarket notification filed by Gerber Products Co. with the FDA for Gerber Precious Care Electric Breast Pump.
Device ID | K891996 |
510k Number | K891996 |
Device Name: | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP |
Classification | Pump, Breast, Powered |
Applicant | GERBER PRODUCTS CO. 445 STATE ST. Fremont, MI 49413 |
Contact | Robert L Lyons |
Correspondent | Robert L Lyons GERBER PRODUCTS CO. 445 STATE ST. Fremont, MI 49413 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-28 |
Decision Date | 1989-08-07 |