The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Aerosol Delivery Systems.
Device ID | K920842 |
510k Number | K920842 |
Device Name: | AEROSOL DELIVERY SYSTEMS |
Classification | Applicator, Ent Drug |
Applicant | HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
Contact | William J Lacey |
Correspondent | William J Lacey HOSPITAK, INC. 1144 ROUTE 109 Lindenhurst, NY 11757 |
Product Code | LRD |
CFR Regulation Number | 874.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-24 |
Decision Date | 1992-05-15 |