The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Masterpieces Micro System.
Device ID | K910957 |
510k Number | K910957 |
Device Name: | MASTERPIECES MICRO SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Michael T Taggart |
Correspondent | Michael T Taggart STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-06 |
Decision Date | 1991-07-26 |