The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Temporary Resin.
Device ID | K961199 |
510k Number | K961199 |
Device Name: | BOSWORTH TEMPORARY RESIN |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
Contact | Mildred M Goldstein |
Correspondent | Mildred M Goldstein HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-27 |
Decision Date | 1996-06-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H66809218081 | K961199 | 000 |
H66809218071 | K961199 | 000 |
H66809218061 | K961199 | 000 |
H66809218051 | K961199 | 000 |
H66809218041 | K961199 | 000 |
H66809213531 | K961199 | 000 |