The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Unimat 45.
| Device ID | K981703 |
| 510k Number | K981703 |
| Device Name: | KSEA UNIMAT 45 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-14 |
| Decision Date | 1998-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551405628 | K981703 | 000 |