The following data is part of a premarket notification filed by Patton Medical Corp. with the FDA for Funnel Trocar.
Device ID | K992324 |
510k Number | K992324 |
Device Name: | FUNNEL TROCAR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | PATTON MEDICAL CORP. 1000 WESTBANK DR. SUITE 5A200 Austin, TX 78746 |
Contact | Michael T Patton |
Correspondent | Michael T Patton PATTON MEDICAL CORP. 1000 WESTBANK DR. SUITE 5A200 Austin, TX 78746 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-12 |
Decision Date | 1999-08-19 |
Summary: | summary |