The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Semi-rigid Hysteroscope And Accessories.
| Device ID | K971518 |
| 510k Number | K971518 |
| Device Name: | KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES |
| Classification | Hysteroscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marllena Allen Piercy |
| Correspondent | Marllena Allen Piercy KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 1997-04-25 |
| Decision Date | 1997-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551405536 | K971518 | 000 |
| 04048551276006 | K971518 | 000 |
| 04048551094426 | K971518 | 000 |
| 04048551083499 | K971518 | 000 |
| 04048551094532 | K971518 | 000 |