The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Scissors For Endoscopic And Laparoscopic Procedures.
Device ID | K940346 |
510k Number | K940346 |
Device Name: | SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Contact | Johathan S Kahan |
Correspondent | Johathan S Kahan KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-25 |
Decision Date | 1994-05-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551457337 | K940346 | 000 |
04048551456842 | K940346 | 000 |