The following data is part of a premarket notification filed by Sasmar Inc with the FDA for Sasmar Original, Sasmar Classic.
Device ID | K131084 |
510k Number | K131084 |
Device Name: | SASMAR ORIGINAL, SASMAR CLASSIC |
Classification | Lubricant, Personal |
Applicant | SASMAR INC 155 NORTH WACKER DR, STE 4250 Chicago, IL 60606 |
Contact | John-michael Mancini |
Correspondent | John-michael Mancini SASMAR INC 155 NORTH WACKER DR, STE 4250 Chicago, IL 60606 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-18 |
Decision Date | 2013-09-13 |
Summary: | summary |