The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Homepump Nsf.
Device ID | K932740 |
510k Number | K932740 |
Device Name: | HOMEPUMP NSF |
Classification | Sterilant, Medical Devices |
Applicant | BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
Contact | Ian Kennedy |
Correspondent | Ian Kennedy BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
Product Code | MED |
CFR Regulation Number | 880.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-08 |
Decision Date | 1993-10-06 |