The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Take-apart Rotating Grasping Forceps.
Device ID | K952149 |
510k Number | K952149 |
Device Name: | KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS |
Classification | Dislodger, Stone, Biliary |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Marika Anderson |
Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | LQR |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-08 |
Decision Date | 1995-06-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551168011 | K952149 | 000 |