The following data is part of a premarket notification filed by Percussionaire Corp. with the FDA for Rate Increase For Ippb/ipv.
Device ID | K896586 |
510k Number | K896586 |
Device Name: | RATE INCREASE FOR IPPB/IPV |
Classification | Tube, Orthodontic |
Applicant | PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864 |
Contact | Bird, Md |
Correspondent | Bird, Md PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864 |
Product Code | DZD |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-22 |
Decision Date | 1990-01-09 |