The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Contoured Anatomical Plating Instrument.
Device ID | K873926 |
510k Number | K873926 |
Device Name: | STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT |
Classification | Plate, Bone |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Dan Regan |
Correspondent | Dan Regan STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-25 |
Decision Date | 1988-02-19 |