The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Laparoscopic Retractor.
Device ID | K933075 |
510k Number | K933075 |
Device Name: | LAPAROSCOPIC RETRACTOR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
Contact | Jill Schweiger |
Correspondent | Jill Schweiger ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-23 |
Decision Date | 1994-02-03 |