The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Beach Excavator's No. 1 & No. 2.
Device ID | K821790 |
510k Number | K821790 |
Device Name: | BEACH EXCAVATOR'S NO. 1 & NO. 2 |
Classification | Instrument, Cutting, Operative |
Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EKD |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-17 |
Decision Date | 1982-07-06 |