The following data is part of a premarket notification filed by Grass-telefactor Product Group with the FDA for Dd-vcr-64.
Device ID | K870381 |
510k Number | K870381 |
Device Name: | DD-VCR-64 |
Classification | Conditioner, Signal, Physiological |
Applicant | GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
Contact | John B Chatten |
Correspondent | John B Chatten GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
Product Code | GWK |
CFR Regulation Number | 882.1845 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-29 |
Decision Date | 1987-03-25 |