The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Oscillating Bone Saw Blade, 6200 Series.
Device ID | K934390 |
510k Number | K934390 |
Device Name: | OSCILLATING BONE SAW BLADE, 6200 SERIES |
Classification | Blade, Saw, General & Plastic Surgery, Surgical |
Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Contact | John Karpowicz |
Correspondent | John Karpowicz BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Product Code | GFA |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-09 |
Decision Date | 1994-01-26 |