The following data is part of a premarket notification filed by Pharma Systems, Inc. with the FDA for Hme-10 (tm).
Device ID | K903054 |
510k Number | K903054 |
Device Name: | HME-10 (TM) |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville, NJ 07924 |
Contact | Hal Norris |
Correspondent | Hal Norris PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville, NJ 07924 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-11 |
Decision Date | 1990-10-31 |