The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Hempfling Dilation Set.
| Device ID | K954981 |
| 510k Number | K954981 |
| Device Name: | KARL STORZ HEMPFLING DILATION SET |
| Classification | Arthroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren 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 | 1995-10-31 |
| Decision Date | 1995-12-04 |