The following data is part of a premarket notification filed by Medi-dose, Inc. with the FDA for 2 Micron Air Eliminating Filter.
Device ID | K942532 |
510k Number | K942532 |
Device Name: | 2 MICRON AIR ELIMINATING FILTER |
Classification | Filter, Infusion Line |
Applicant | MEDI-DOSE, INC. 1671 LORETTA AVE. Feasterville, PA 19053 |
Contact | Milton Braverman |
Correspondent | Milton Braverman MEDI-DOSE, INC. 1671 LORETTA AVE. Feasterville, PA 19053 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-27 |
Decision Date | 1994-08-17 |