The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Orthopedics Drill Bits.
Device ID | K931734 |
510k Number | K931734 |
Device Name: | INTERMEDICS ORTHOPEDICS DRILL BITS |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Joann Ringer |
Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-07 |
Decision Date | 1994-02-22 |