The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Computed Oral Radiology System.
Device ID | K933455 |
510k Number | K933455 |
Device Name: | COMPUTED ORAL RADIOLOGY SYSTEM |
Classification | Unit, X-ray, Intraoral |
Applicant | SCHICK TECHNOLOGIES, INC. 30 NORTHPORT RD. Sound Beach, NY 11789 |
Contact | Richard C Lanzillotto |
Correspondent | Richard C Lanzillotto SCHICK TECHNOLOGIES, INC. 30 NORTHPORT RD. Sound Beach, NY 11789 |
Product Code | EAP |
CFR Regulation Number | 872.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-14 |
Decision Date | 1994-01-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D764B10730701 | K933455 | 000 |
D76464286481 | K933455 | 000 |
D764B10351060 | K933455 | 000 |
D764B11121000 | K933455 | 000 |
D764B1204050R1 | K933455 | 000 |
D764B1303050R1 | K933455 | 000 |
D764B22500001 | K933455 | 000 |
D764B22501000 | K933455 | 000 |
D76461736321 | K933455 | 000 |
D764B10710071 | K933455 | 000 |
D764B10710231 | K933455 | 000 |
D764B10730611 | K933455 | 000 |
D76461443511 | K933455 | 000 |