The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Subglottiscope, Neonate And Infant, Fiber Optic Light Carrier, Suction Tube.
| Device ID | K951804 |
| 510k Number | K951804 |
| Device Name: | KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE |
| Classification | Laryngoscope, Rigid |
| 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 | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-19 |
| Decision Date | 1995-06-05 |