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 |