The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Supergel/suppressed Dust.
Device ID | K940402 |
510k Number | K940402 |
Device Name: | SUPERGEL/SUPPRESSED DUST |
Classification | Material, Impression |
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 | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-27 |
Decision Date | 1994-03-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6680921839SR1 | K940402 | 000 |
H6684000121 | K940402 | 000 |
H66809218221 | K940402 | 000 |
H66809218231 | K940402 | 000 |
H66809218271 | K940402 | 000 |
H66809218301 | K940402 | 000 |
H6680921831F1 | K940402 | 000 |
H6680921832F1 | K940402 | 000 |
H6680921839SF1 | K940402 | 000 |
H6684000111 | K940402 | 000 |