The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Laparoscope, Hand Instruments.
Device ID | K950103 |
510k Number | K950103 |
Device Name: | LAPAROSCOPE, HAND INSTRUMENTS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
Contact | Barry E Sands |
Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-11 |
Decision Date | 1995-03-06 |