The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Cdr - Pan Model 4700.
Device ID | K982661 |
510k Number | K982661 |
Device Name: | CDR - PAN MODEL 4700 |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | SCHICK TECHNOLOGIES, INC. 3100 47TH AVE. Long Island, NY 11101 |
Contact | Enrico Renzi |
Correspondent | Enrico Renzi SCHICK TECHNOLOGIES, INC. 3100 47TH AVE. Long Island, NY 11101 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-30 |
Decision Date | 1998-12-11 |