The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Rostam Ltd Fragranced Plastic Applicator Tampons.
Device ID | K032080 |
510k Number | K032080 |
Device Name: | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | ROSTAM LTD. 73 FRANKLIN TPK. Allendale, NJ 07401 |
Contact | Robert J Staab |
Correspondent | Robert J Staab ROSTAM LTD. 73 FRANKLIN TPK. Allendale, NJ 07401 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-07 |
Decision Date | 2003-08-14 |
Summary: | summary |