The following data is part of a premarket notification filed by Composites Horizons, Inc. with the FDA for Mtd Hedrest.
Device ID | K884847 |
510k Number | K884847 |
Device Name: | MTD HEDREST |
Classification | Holder, Head, Radiographic |
Applicant | COMPOSITES HORIZONS, INC. 1471 INDUSTRIAL PARK ST. Covina, CA 91722 |
Contact | M. H Anderson |
Correspondent | M. H Anderson COMPOSITES HORIZONS, INC. 1471 INDUSTRIAL PARK ST. Covina, CA 91722 |
Product Code | IWY |
CFR Regulation Number | 892.1920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-21 |
Decision Date | 1989-01-09 |