The following data is part of a premarket notification filed by Good Clean Love, Inc. with the FDA for Good Clean Love Personal Lubricants Almost Naked And Natural Cinnamon Vanilla.
Device ID | K150094 |
510k Number | K150094 |
Device Name: | Good Clean Love Personal Lubricants Almost Naked And Natural Cinnamon Vanilla |
Classification | Lubricant, Personal |
Applicant | Good Clean Love, Inc. 207 West 5th Avenue Eugene, OR 97401 |
Contact | Wendy Strgar |
Correspondent | Steven Chernoff Drug & Device Development Co., Inc. P.O. Box 3515 Redmont, WA 98073 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-16 |
Decision Date | 2015-11-19 |
Summary: | summary |