The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex And Other Proprietary Names.
Device ID | K122603 |
510k Number | K122603 |
Device Name: | ONTEX AND OTHER PROPRIETARY NAMES |
Classification | Tampon, Menstrual, Unscented |
Applicant | ONTEX BVBA 30 NECK ROAD Old Lyme, CT 06371 |
Contact | Robert J Staab |
Correspondent | Robert J Staab ONTEX BVBA 30 NECK ROAD Old Lyme, CT 06371 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-27 |
Decision Date | 2012-12-19 |
Summary: | summary |