The following data is part of a premarket notification filed by Terray Manufacturing, Inc. with the FDA for Casf Drill Guide Dg 170.
Device ID | K882871 |
510k Number | K882871 |
Device Name: | CASF DRILL GUIDE DG 170 |
Classification | Accessories, Fixation, Spinal Intervertebral Body |
Applicant | TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
Contact | Judy Wilson |
Correspondent | Judy Wilson TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
Product Code | LYQ |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-11 |
Decision Date | 1988-09-23 |