The following data is part of a premarket notification filed by Pigeon Corp. with the FDA for Deluxe Magmag Breast Pump.
Device ID | K936309 |
510k Number | K936309 |
Device Name: | DELUXE MAGMAG BREAST PUMP |
Classification | Pump, Breast, Powered |
Applicant | PIGEON CORP. 5-1, TOMIYAMA-CHO, KANDA, CHIYODA-KU Tokyo, JP 101 |
Contact | Kenji Omura |
Correspondent | Kenji Omura 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 | 1994-11-30 |