The following data is part of a premarket notification filed by Dentech Corp. with the FDA for Dental Delivery System.
Device ID | K896532 |
510k Number | K896532 |
Device Name: | DENTAL DELIVERY SYSTEM |
Classification | Unit, Operative Dental |
Applicant | DENTECH CORP. P.O. BOX 157 529 WEST FRONT ST. Sumas, WA 98295 |
Contact | Al Kennedy |
Correspondent | Al Kennedy DENTECH CORP. P.O. BOX 157 529 WEST FRONT ST. Sumas, WA 98295 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-14 |
Decision Date | 1990-02-12 |