The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Laryngoscope Accessories.
| Device ID | K944295 |
| 510k Number | K944295 |
| Device Name: | KARL STORZ LARYNGOSCOPE ACCESSORIES |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| 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 | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1994-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551104323 | K944295 | 000 |