The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Insulated Biopsy Forceps, Grasping/dissecting Forecps, Flexible Forceps.
Device ID | K944765 |
510k Number | K944765 |
Device Name: | KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS |
Classification | Forceps, Biopsy, Electric |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Betty M Johnson |
Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | KGE |
Subsequent Product Code | FDI |
Subsequent Product Code | GDI |
Subsequent Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-27 |
Decision Date | 1995-03-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551056028 | K944765 | 000 |
04048551055779 | K944765 | 000 |
04048551055700 | K944765 | 000 |