The following data is part of a premarket notification filed by Goldsmith & Revere, Inc. with the FDA for Goldsmith & Revere Tenary Alloy.
| Device ID | K821222 |
| 510k Number | K821222 |
| Device Name: | GOLDSMITH & REVERE TENARY ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | GOLDSMITH & REVERE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889813001537 | K821222 | 000 |
| D03309955044A1 | K821222 | 000 |
| D033099550621 | K821222 | 000 |
| D03309955062A1 | K821222 | 000 |
| D033099550631 | K821222 | 000 |
| D03309955063A1 | K821222 | 000 |
| D033099550641 | K821222 | 000 |
| D03309955064B1 | K821222 | 000 |
| D033099650071 | K821222 | 000 |
| D033099650081 | K821222 | 000 |
| D033099650091 | K821222 | 000 |
| D033099650131 | K821222 | 000 |
| D033099650141 | K821222 | 000 |
| D033099650151 | K821222 | 000 |
| D033099550441 | K821222 | 000 |
| D03309955039A1 | K821222 | 000 |
| D033099550391 | K821222 | 000 |
| 10889813001544 | K821222 | 000 |
| 10889813001551 | K821222 | 000 |
| 10889813001568 | K821222 | 000 |
| 10889813001575 | K821222 | 000 |
| 10889813001582 | K821222 | 000 |
| 20889813001534 | K821222 | 000 |
| 20889813001541 | K821222 | 000 |
| 20889813001558 | K821222 | 000 |
| 20889813001565 | K821222 | 000 |
| 20889813001572 | K821222 | 000 |
| 20889813001589 | K821222 | 000 |
| D033099550381 | K821222 | 000 |
| D03309955038A1 | K821222 | 000 |
| D033099651031 | K821222 | 000 |
| D033099651041 | K821222 | 000 |
| H65811272751 | K821222 | 000 |
| H65811272761 | K821222 | 000 |
| H65811272771 | K821222 | 000 |
| H65811272791 | K821222 | 000 |
| H65811272801 | K821222 | 000 |
| H65811272811 | K821222 | 000 |
| H65811272821 | K821222 | 000 |
| H65811272831 | K821222 | 000 |
| D773100UTD15001 | K821222 | 000 |
| D773100UTD25001 | K821222 | 000 |
| D773100UTD2500RS1 | K821222 | 000 |
| D773100UTD35001 | K821222 | 000 |
| D773100UTD3500RS1 | K821222 | 000 |
| H65810091251 | K821222 | 000 |
| H65810090501 | K821222 | 000 |
| H65810081911 | K821222 | 000 |
| D033099651051 | K821222 | 000 |
| D773100UTD1501 | K821222 | 000 |
| D773100UTD150RS1 | K821222 | 000 |
| D773100UTD2501 | K821222 | 000 |
| D773100UTD250RS1 | K821222 | 000 |
| D773100UTD3501 | K821222 | 000 |
| H65810002251 | K821222 | 000 |
| H65810021531 | K821222 | 000 |
| H65810039461 | K821222 | 000 |
| H65810059661 | K821222 | 000 |
| H65810060371 | K821222 | 000 |
| H65810072111 | K821222 | 000 |
| H65810081821 | K821222 | 000 |
| D773100UTD350RS1 | K821222 | 000 |