The following data is part of a premarket notification filed by Tosama D.o.o. with the FDA for Tosama 100% Organic Cotton Menstrual Tampon.
Device ID | K151170 |
510k Number | K151170 |
Device Name: | Tosama 100% Organic Cotton Menstrual Tampon |
Classification | Tampon, Menstrual, Unscented |
Applicant | TOSAMA D.O.O. SARANOVICEVA CESTA 35 VIR Vir, Domzale, SI 1230 |
Contact | Marjetka Kralj Kuncic |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2015-05-01 |
Decision Date | 2015-07-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860178002653 | K151170 | 000 |
00860178002646 | K151170 | 000 |
00860178002639 | K151170 | 000 |
00860178002622 | K151170 | 000 |
00860178002615 | K151170 | 000 |
00860178002608 | K151170 | 000 |