The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Sawahle Electromechanical Morcellator.
Device ID | K010346 |
510k Number | K010346 |
Device Name: | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | James A Lee |
Correspondent | Leigh Spotten KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-05 |
Decision Date | 2001-05-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551071014 | K010346 | 000 |
04048551070710 | K010346 | 000 |