The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Kd Series Sphincterotome.
Device ID | K955247 |
510k Number | K955247 |
Device Name: | OLYMPUS KD SERIES SPHINCTEROTOME |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Subhash Patel |
Correspondent | Subhash Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-15 |
Decision Date | 1996-04-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170382717 | K955247 | 000 |
14953170038102 | K955247 | 000 |
14953170038157 | K955247 | 000 |
14953170038201 | K955247 | 000 |
14953170038256 | K955247 | 000 |
14953170038300 | K955247 | 000 |
14953170038355 | K955247 | 000 |
14953170038409 | K955247 | 000 |
14953170038454 | K955247 | 000 |
14953170038706 | K955247 | 000 |
14953170038751 | K955247 | 000 |
14953170038850 | K955247 | 000 |
04953170039379 | K955247 | 000 |
14953170244121 | K955247 | 000 |
14953170244145 | K955247 | 000 |
14953170382700 | K955247 | 000 |
14953170038058 | K955247 | 000 |