The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Laparoscopic Clamp.
Device ID | K950702 |
510k Number | K950702 |
Device Name: | LAPAROSCOPIC CLAMP |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
Contact | Howard V Rowe |
Correspondent | Howard V Rowe APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-15 |
Decision Date | 1995-05-25 |