The following data is part of a premarket notification filed by Midwest Dental Products Corp. with the FDA for 23:1 Reduction Angle.
Device ID | K973800 |
510k Number | K973800 |
Device Name: | 23:1 REDUCTION ANGLE |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
Contact | Robert E Booth |
Correspondent | Robert E Booth MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-06 |
Decision Date | 1998-03-11 |