The following data is part of a premarket notification filed by Crane Dental Laboratory, Inc. with the FDA for Crane Acrylic Herbst Appliance.
Device ID | K140429 |
510k Number | K140429 |
Device Name: | CRANE ACRYLIC HERBST APPLIANCE |
Classification | Device, Anti-snoring |
Applicant | CRANE DENTAL LABORATORY, INC. 200 AIRPARK DRIVE, SUITE 30 Rochester, NY 14624 |
Contact | Kate Young |
Correspondent | Kate Young CRANE DENTAL LABORATORY, INC. 200 AIRPARK DRIVE, SUITE 30 Rochester, NY 14624 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-19 |
Decision Date | 2014-09-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860009255616 | K140429 | 000 |