The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Silicone Tubing.
| Device ID | K955433 |
| 510k Number | K955433 |
| Device Name: | DURALASTIC SILICONE TUBING |
| Classification | Accessories, Catheter |
| Applicant | ALLIED BIOMEDICAL CORP. 3850 DR. #C-2 Paso Robles, CA 93446 |
| Contact | Gerald Hanson |
| Correspondent | Gerald Hanson ALLIED BIOMEDICAL CORP. 3850 DR. #C-2 Paso Robles, CA 93446 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724PAT111 | K955433 | 000 |
| M724HAT221 | K955433 | 000 |
| M724HAT211 | K955433 | 000 |
| M724HAT201 | K955433 | 000 |
| M724HAT191 | K955433 | 000 |
| M724HAT181 | K955433 | 000 |
| M724HAT171 | K955433 | 000 |
| M724HAT161 | K955433 | 000 |
| M724HAT151 | K955433 | 000 |
| M724HAT141 | K955433 | 000 |
| M724HAT131 | K955433 | 000 |
| M724HAT231 | K955433 | 000 |
| M724HAT241 | K955433 | 000 |
| M724PAT101 | K955433 | 000 |
| M724PAT091 | K955433 | 000 |
| M724PAT081 | K955433 | 000 |
| M724PAT071 | K955433 | 000 |
| M724PAT061 | K955433 | 000 |
| M724PAT051 | K955433 | 000 |
| M724PAT041 | K955433 | 000 |
| M724PAT031 | K955433 | 000 |
| M724PAT021 | K955433 | 000 |
| M724PAT011 | K955433 | 000 |
| M724HAT121 | K955433 | 000 |