The following data is part of a premarket notification filed by Pigeon Corp. with the FDA for Advanced Magmag Ac/battery Breast Pump.
Device ID | K935249 |
510k Number | K935249 |
Device Name: | ADVANCED MAGMAG AC/BATTERY BREAST PUMP |
Classification | Pump, Breast, Powered |
Applicant | PIGEON CORP. 5-1, TOMIYAMA-CHO, KANDA, CHIYODA-KU Tokyo, JP 101 |
Contact | Mitsuo Tsuchiya |
Correspondent | Mitsuo Tsuchiya PIGEON CORP. 5-1, TOMIYAMA-CHO, KANDA, CHIYODA-KU Tokyo, JP 101 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-01 |
Decision Date | 1994-11-22 |