The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Flexible Hysterscope.
Device ID | K952779 |
510k Number | K952779 |
Device Name: | KARL STORZ FLEXIBLE HYSTERSCOPE |
Classification | Hysteroscope (and Accessories) |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Marika Anderson |
Correspondent | Marika Anderson 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 | 1995-06-16 |
Decision Date | 1995-10-05 |