The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ecliptomer.
Device ID | K945604 |
510k Number | K945604 |
Device Name: | ECLIPTOMER |
Classification | Agent, Tooth Bonding, Resin |
Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
Contact | James L Sandrik |
Correspondent | James L Sandrik BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-15 |
Decision Date | 1995-01-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D8281330225 | K945604 | 000 |
D867CLABP0 | K945604 | 000 |