The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Stortz Obturator)sharp/blunt)/cannulae/sheaths.
Device ID | K943154 |
510k Number | K943154 |
Device Name: | KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-30 |
Decision Date | 1994-12-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551095836 | K943154 | 000 |
04048551094723 | K943154 | 000 |