The following data is part of a premarket notification filed by Icm Pharma Pte Ltd with the FDA for Superslyde Personal Lubricant.
Device ID | K172306 |
510k Number | K172306 |
Device Name: | SuperSlyde Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | ICM Pharma Pte Ltd 26 Kallang Place #05-17 Singapore, SG 339157 |
Contact | Dennis Fortich |
Correspondent | Moturi Srinivasa Rao ICM Pharma Pte Ltd 26 Kallang Place #05-17 Singapore, SG 339157 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-31 |
Decision Date | 2018-04-19 |
Summary: | summary |