The following data is part of a premarket notification filed by Tso3 Inc. with the FDA for Tso3 Ozone Sterilization Wrap.
Device ID | K080198 |
510k Number | K080198 |
Device Name: | TSO3 OZONE STERILIZATION WRAP |
Classification | Wrap, Sterilization |
Applicant | TSO3 INC. 33 BLACK WATCH TRAIL Fairport, NY 14450 |
Contact | Charles O Hancock |
Correspondent | Charles O Hancock TSO3 INC. 33 BLACK WATCH TRAIL Fairport, NY 14450 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-25 |
Decision Date | 2008-05-30 |
Summary: | summary |