The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Turkel Thoracentesis Needle.
| Device ID | K921461 |
| 510k Number | K921461 |
| Device Name: | TURKEL THORACENTESIS NEEDLE |
| Classification | Antisera, Fluorescent, Pseudomonas Aeruginosa |
| 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 | GSS |
| CFR Regulation Number | 866.3415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1992-07-30 |