The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Remorgida Forceps.
| Device ID | K962030 |
| 510k Number | K962030 |
| Device Name: | KARL STORZ REMORGIDA FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-24 |
| Decision Date | 1996-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551372524 | K962030 | 000 |
| 04048551359389 | K962030 | 000 |
| 04048551331354 | K962030 | 000 |
| 04048551325193 | K962030 | 000 |
| 04048551325186 | K962030 | 000 |
| 04048551325179 | K962030 | 000 |
| 04048551325162 | K962030 | 000 |