The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Yankauer With Connecting Tubing.
Device ID | K934750 |
510k Number | K934750 |
Device Name: | YANKAUER WITH CONNECTING TUBING |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Contact | Partha Basumallik |
Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-04 |
Decision Date | 1994-02-17 |