The following data is part of a premarket notification filed by Perrigo New York, Inc. with the FDA for Personal Lubricating Jelly.
Device ID | K180923 |
510k Number | K180923 |
Device Name: | Personal Lubricating Jelly |
Classification | Lubricant, Personal |
Applicant | Perrigo New York, Inc. 1700 Bathgate Ave. Bronx, NY 10457 -7512 |
Contact | Karen Dombrowski |
Correspondent | Phil Triolo Phil Triolo And Associates LC 86 Skycrest Land Salt Lake City, UT 84108 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-09 |
Decision Date | 2018-07-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10041220823229 | K180923 | 000 |