The following data is part of a premarket notification filed by Catalina, Inc. with the FDA for Nasal Cease.
Device ID | K102742 |
510k Number | K102742 |
Device Name: | NASAL CEASE |
Classification | Dressing, Wound, Drug |
Applicant | CATALINA, INC. 8110 WESTBURY DR. Richmond, VA 23229 |
Contact | Richard J Freer |
Correspondent | Richard J Freer CATALINA, INC. 8110 WESTBURY DR. Richmond, VA 23229 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-22 |
Decision Date | 2011-02-02 |
Summary: | summary |