The following data is part of a premarket notification filed by Phillip C. Crawford, D.d.s. with the FDA for Indentec Drill Ra #1.
Device ID | K884187 |
510k Number | K884187 |
Device Name: | INDENTEC DRILL RA #1 |
Classification | Drill, Dental, Intraoral |
Applicant | PHILLIP C. CRAWFORD, D.D.S. 190 W. SPANISH RIVER BLVD. Boca Raton, FL 33431 |
Contact | C Crawford |
Correspondent | C Crawford PHILLIP C. CRAWFORD, D.D.S. 190 W. SPANISH RIVER BLVD. Boca Raton, FL 33431 |
Product Code | DZA |
CFR Regulation Number | 872.4130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-05 |
Decision Date | 1988-12-22 |