The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Hydragamma 16.
Device ID | K800601 |
510k Number | K800601 |
Device Name: | HYDRAGAMMA 16 |
Classification | Counter (beta, Gamma) For Clinical Use |
Applicant | INNOTRON OF OREGON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJJ |
CFR Regulation Number | 862.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-17 |
Decision Date | 1980-04-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYDRAGAMMA 16 73259116 1184522 Dead/Cancelled |
Innotron Limited 1980-04-21 |