The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Scb/steris Or-light Interface Box.
| Device ID | K051505 |
| 510k Number | K051505 |
| Device Name: | SCB/STERIS OR-LIGHT INTERFACE BOX |
| Classification | Light, Surgical, Accessories |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Paul S Lee |
| Correspondent | Paul S Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2005-08-11 |
| Summary: | summary |