The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Continuous Flow Hystero-resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C.
| Device ID | K991563 |
| 510k Number | K991563 |
| Device Name: | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C |
| Classification | Hysteroscope (and Accessories) |
| Applicant | HENKE SASS WOLF OF AMERICA, INC. 73 EAGLES NEST RD. Duxbury, MA 02332 |
| Contact | Ellen Henke |
| Correspondent | Ellen Henke HENKE SASS WOLF OF AMERICA, INC. 73 EAGLES NEST RD. Duxbury, MA 02332 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-05 |
| Decision Date | 1999-10-13 |
| Summary: | summary |