The following data is part of a premarket notification filed by The Huxley Instrument Corp. with the FDA for Tooth Extracting Forceps 151(2010)-875 Pcs. Ss410/.
Device ID | K851105 |
510k Number | K851105 |
Device Name: | TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ |
Classification | Forceps, Tooth Extractor, Surgical |
Applicant | THE HUXLEY INSTRUMENT CORP. 215 MAIN ST. Penn Yan, NY 14527 |
Contact | Rebecca J Shahzada |
Correspondent | Rebecca J Shahzada THE HUXLEY INSTRUMENT CORP. 215 MAIN ST. Penn Yan, NY 14527 |
Product Code | EMG |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-19 |
Decision Date | 1985-05-15 |