The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for The Karl Storz Model 28805 Arthro Pump.
| Device ID | K871621 |
| 510k Number | K871621 |
| Device Name: | THE KARL STORZ MODEL 28805 ARTHRO PUMP |
| Classification | Arthroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Norman Silbertrust |
| Correspondent | Norman Silbertrust KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-06-05 |