The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Silclear Tubing (modification).
| Device ID | K953864 |
| 510k Number | K953864 |
| Device Name: | SILCLEAR TUBING (MODIFICATION) |
| Classification | Tubing, Fluid Delivery |
| Applicant | DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Contact | Bette Lubin |
| Correspondent | Bette Lubin DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1995-11-06 |
| Summary: | summary |