The following data is part of a premarket notification filed by Goldsmith & Revere, Inc. with the FDA for Dispersed Phase Alloy.
Device ID | K820617 |
510k Number | K820617 |
Device Name: | DISPERSED PHASE 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 | 1982-03-08 |
Decision Date | 1982-03-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10889813001599 | K820617 | 000 |
D033099550731 | K820617 | 000 |
D033099550721 | K820617 | 000 |
D033099550711 | K820617 | 000 |
D033099550701 | K820617 | 000 |
D033099550691 | K820617 | 000 |
D033099550681 | K820617 | 000 |
D033099550551 | K820617 | 000 |
D033099550541 | K820617 | 000 |
D033099600001 | K820617 | 000 |
D033099610011 | K820617 | 000 |
D033099610171 | K820617 | 000 |
D033099610161 | K820617 | 000 |
D033099610131 | K820617 | 000 |
D033099610121 | K820617 | 000 |
D033099610091 | K820617 | 000 |
D033099610081 | K820617 | 000 |
D033099610051 | K820617 | 000 |
D033099610041 | K820617 | 000 |
D033099550531 | K820617 | 000 |
D033099550521 | K820617 | 000 |
20889813001619 | K820617 | 000 |
20889813001602 | K820617 | 000 |
20889813001596 | K820617 | 000 |
10889813001643 | K820617 | 000 |
10889813001636 | K820617 | 000 |
10889813001629 | K820617 | 000 |
10889813001612 | K820617 | 000 |
10889813001605 | K820617 | 000 |
20889813001626 | K820617 | 000 |
20889813001633 | K820617 | 000 |
D033099550511 | K820617 | 000 |
D033099550501 | K820617 | 000 |
D023Q0550303 | K820617 | 000 |
D023Q0550263 | K820617 | 000 |
D023Q0550223 | K820617 | 000 |
D023Q0550073 | K820617 | 000 |
D023Q0550031 | K820617 | 000 |
20889813001640 | K820617 | 000 |
D033099610201 | K820617 | 000 |
D033099610211 | K820617 | 000 |
H65810028501 | K820617 | 000 |
H65810023621 | K820617 | 000 |
H65810020521 | K820617 | 000 |
H65810020491 | K820617 | 000 |
H65810007411 | K820617 | 000 |
D850JBAA800501 | K820617 | 000 |
D850JBAA600501 | K820617 | 000 |
D850JBAA400501 | K820617 | 000 |
H65810040021 | K820617 | 000 |
H65810045141 | K820617 | 000 |
H65810095401 | K820617 | 000 |
H65810089011 | K820617 | 000 |
H65810077651 | K820617 | 000 |
H65810077211 | K820617 | 000 |
H65810075291 | K820617 | 000 |
H65810061931 | K820617 | 000 |
H65810057481 | K820617 | 000 |
H65810054471 | K820617 | 000 |
D773100UPD350RS1 | K820617 | 000 |
D773100UPD3501 | K820617 | 000 |
D033099612091 | K820617 | 000 |
D033099612081 | K820617 | 000 |
D033099612071 | K820617 | 000 |
D033099612061 | K820617 | 000 |
D033099610291 | K820617 | 000 |
D033099610281 | K820617 | 000 |
D033099610251 | K820617 | 000 |
D033099610241 | K820617 | 000 |
D033099612101 | K820617 | 000 |
D033099612111 | K820617 | 000 |
D773100UPD3500RS1 | K820617 | 000 |
D773100UPD35001 | K820617 | 000 |
D773100UPD250RS1 | K820617 | 000 |
D773100UPD2501 | K820617 | 000 |
D773100UPD2500RS1 | K820617 | 000 |
D773100UPD25001 | K820617 | 000 |
D773100UPD1501 | K820617 | 000 |
D773100UPD1500RS1 | K820617 | 000 |
H65810096471 | K820617 | 000 |