The following data is part of a premarket notification filed by Package Solutions Llc with the FDA for Swiss Navy Premium Silicone Lubricant;swiss Navy Premium Water Based Lubricant;swiss Navy Premium All Natural Lubricant.
Device ID | K150153 |
510k Number | K150153 |
Device Name: | Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant |
Classification | Lubricant, Personal |
Applicant | Package Solutions LLC 2131 Blount Road Pompano Beach, FL 33069 |
Contact | Jack Scalisi |
Correspondent | Jack Scalisi Package Solutions LLC 2131 Blount Road Pompano Beach, FL 33069 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-23 |
Decision Date | 2015-10-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00760236441083 | K150153 | 000 |
00760236441076 | K150153 | 000 |
00760236441045 | K150153 | 000 |