The following data is part of a premarket notification filed by Medi-dose, Inc. with the FDA for Disposable Disc Filter.
Device ID | K936015 |
510k Number | K936015 |
Device Name: | DISPOSABLE DISC FILTER |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-16 |
Decision Date | 1994-12-12 |