The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Turkel Abdominal Paracentesis System.
Device ID | K924702 |
510k Number | K924702 |
Device Name: | TURKEL ABDOMINAL PARACENTESIS SYSTEM |
Classification | Catheter, Irrigation |
Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
Contact | Kevin W Smith |
Correspondent | Kevin W Smith SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
Product Code | GBX |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-17 |
Decision Date | 1993-01-12 |