The following data is part of a premarket notification filed by Consumer Health Products, Inc with the FDA for Snorerx 9.0.
Device ID | K112205 |
510k Number | K112205 |
Device Name: | SNORERX 9.0 |
Classification | Device, Anti-snoring |
Applicant | CONSUMER HEALTH PRODUCTS, INC 49 COASTAL OAK Aliso Viejo, CA 92656 |
Contact | Gary Mocnik |
Correspondent | Gary Mocnik CONSUMER HEALTH PRODUCTS, INC 49 COASTAL OAK Aliso Viejo, CA 92656 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-01 |
Decision Date | 2011-11-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861481000305 | K112205 | 000 |