The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Model 203020 20 Equimat.
| Device ID | K961091 |
| 510k Number | K961091 |
| Device Name: | KARL STORZ MODEL 203020 20 EQUIMAT |
| Classification | Insufflator, Hysteroscopic |
| 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 | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551065358 | K961091 | 000 |