The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Beach Anesthetic Syringe Cartr. Type.
Device ID | K821782 |
510k Number | K821782 |
Device Name: | BEACH ANESTHETIC SYRINGE CARTR. TYPE |
Classification | Syringe, Cartridge |
Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-17 |
Decision Date | 1982-07-20 |