The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Integrated Endosurgery System Endoalpha.
| Device ID | K981993 |
| 510k Number | K981993 |
| Device Name: | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA |
| Classification | Endoscopic Central Control Unit |
| Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-08 |
| Decision Date | 1998-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170355837 | K981993 | 000 |
| 04953170136597 | K981993 | 000 |
| 04953170028410 | K981993 | 000 |
| 04953170028335 | K981993 | 000 |
| 04953170144929 | K981993 | 000 |