The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Hand Extractor Hector.
| Device ID | K953109 |
| 510k Number | K953109 |
| Device Name: | HAND EXTRACTOR HECTOR |
| Classification | Hysteroscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-08-25 |