The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Unidrive Shaver, Arthroscopy Blades.
| Device ID | K952192 |
| 510k Number | K952192 |
| Device Name: | KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES |
| Classification | Arthroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1995-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551020203 | K952192 | 000 |
| 04048551020197 | K952192 | 000 |
| 04048551020173 | K952192 | 000 |
| 04048551405093 | K952192 | 000 |
| 04048551110133 | K952192 | 000 |
| 04048551109267 | K952192 | 000 |
| 04048551020180 | K952192 | 000 |