The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Feldman Mini-saw, #300000.
Device ID | K800669 |
510k Number | K800669 |
Device Name: | FELDMAN MINI-SAW, #300000 |
Classification | Saw, Surgical, Ent (electric Or Pneumatic) |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EWQ |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-26 |
Decision Date | 1980-04-21 |