The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Murdoch Laparoscope Lens Cleaner.
Device ID | K941092 |
510k Number | K941092 |
Device Name: | MURDOCH LAPAROSCOPE LENS CLEANER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | COOK, INC. 925 SOUTH CURRY PK Bloomington, IN 47403 -2624 |
Contact | April Lavender |
Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PK Bloomington, IN 47403 -2624 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-08 |
Decision Date | 1994-04-11 |