The following data is part of a premarket notification filed by Buttner-frank Gmbh with the FDA for Frank Milk Pump.
Device ID | K895114 |
510k Number | K895114 |
Device Name: | FRANK MILK PUMP |
Classification | Pump, Breast, Powered |
Applicant | BUTTNER-FRANK GMBH 8520 ERLANGEN-TENNENLOHE AM WOLFSMANTEL 9/GEWERBEGABIET Postfach 1266, DE |
Contact | Blank |
Correspondent | Blank BUTTNER-FRANK GMBH 8520 ERLANGEN-TENNENLOHE AM WOLFSMANTEL 9/GEWERBEGABIET Postfach 1266, DE |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-15 |
Decision Date | 1990-03-05 |