The following data is part of a premarket notification filed by Worldwide Dental, Inc. with the FDA for Mouth Props.
Device ID | K940785 |
510k Number | K940785 |
Device Name: | MOUTH PROPS |
Classification | Accessories, Retractor, Dental |
Applicant | WORLDWIDE DENTAL, INC. 12890 AUTOMOBILE BLVD., SUITE A Clearwater, FL 34622 -4733 |
Contact | William M Domin |
Correspondent | William M Domin WORLDWIDE DENTAL, INC. 12890 AUTOMOBILE BLVD., SUITE A Clearwater, FL 34622 -4733 |
Product Code | EIF |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-22 |
Decision Date | 1994-10-05 |