The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for 76 Elw Bite Checker Silicone.
| Device ID | K851469 |
| 510k Number | K851469 |
| Device Name: | 76 ELW BITE CHECKER SILICONE |
| Classification | Material, Impression |
| Applicant | G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
| Contact | Donald A Mckenzie |
| Correspondent | Donald A Mckenzie G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6582620251 | K851469 | 000 |