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 |