The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for 28200 Series Micro-arthro. Sterile Disp. Blades.
| Device ID | K881715 |
| 510k Number | K881715 |
| Device Name: | 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES |
| Classification | Arthroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini 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 | 1988-04-21 |
| Decision Date | 1988-08-30 |