The following data is part of a premarket notification filed by St. George Technology, Inc. with the FDA for St. George Technology, Inc Perfection Plus Disposable Prophy Angle.
Device ID | K023953 |
510k Number | K023953 |
Device Name: | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | ST. GEORGE TECHNOLOGY, INC. P.O. BOX 2849 Wilmington, NC 28402 |
Contact | Vernon Watkins |
Correspondent | Vernon Watkins ST. GEORGE TECHNOLOGY, INC. P.O. BOX 2849 Wilmington, NC 28402 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-27 |
Decision Date | 2003-02-14 |
Summary: | summary |