The following data is part of a premarket notification filed by The Jm Kohn Co. with the FDA for Modification To Relief Brief.
Device ID | K003128 |
510k Number | K003128 |
Device Name: | MODIFICATION TO RELIEF BRIEF |
Classification | Orthosis, Truncal, For Dysmenorrhea |
Applicant | THE JM KOHN CO. 201 SPEAR ST. SUITE 1600 San Francisco, CA 94105 -1635 |
Contact | Charles L Morin |
Correspondent | Charles L Morin THE JM KOHN CO. 201 SPEAR ST. SUITE 1600 San Francisco, CA 94105 -1635 |
Product Code | NJB |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-06 |
Decision Date | 2002-08-12 |