The following data is part of a premarket notification filed by Dental Development Services, Inc. with the FDA for Endovage Syringe.
Device ID | K792577 |
510k Number | K792577 |
Device Name: | ENDOVAGE SYRINGE |
Classification | Syringe, Periodontic, Endodontic, Irrigating |
Applicant | DENTAL DEVELOPMENT SERVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EIC |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-14 |
Decision Date | 1980-01-04 |