The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Surgical Obturator With Seal.
Device ID | K911730 |
510k Number | K911730 |
Device Name: | SURGICAL OBTURATOR WITH SEAL |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Contact | Jo Stegwell |
Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #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 | 1991-04-17 |
Decision Date | 1991-12-23 |