The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic I And Duralastic Ii.
| Device ID | K971480 |
| 510k Number | K971480 |
| Device Name: | DURALASTIC I AND DURALASTIC II |
| Classification | Elastomer, Silicone Block |
| Applicant | ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles, CA 93446 |
| Contact | Gerald Hanson |
| Correspondent | Gerald Hanson ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles, CA 93446 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M72423700072 | K971480 | 000 |
| M724700101 | K971480 | 000 |
| M724701071 | K971480 | 000 |
| M724701101 | K971480 | 000 |
| M724701201 | K971480 | 000 |
| M724701301 | K971480 | 000 |
| M724701401 | K971480 | 000 |
| M72423700051 | K971480 | 000 |
| M72423700102 | K971480 | 000 |
| M72423700202 | K971480 | 000 |
| M72423700302 | K971480 | 000 |
| M724601601 | K971480 | 000 |
| M724601401 | K971480 | 000 |
| M72423700152 | K971480 | 000 |
| M72423701102 | K971480 | 000 |
| M72423701302 | K971480 | 000 |
| M724600051 | K971480 | 000 |
| M724600071 | K971480 | 000 |
| M724600101 | K971480 | 000 |
| M724600201 | K971480 | 000 |
| M724600301 | K971480 | 000 |
| M724601071 | K971480 | 000 |
| M724601301 | K971480 | 000 |
| M72423700402 | K971480 | 000 |
| M72423701072 | K971480 | 000 |
| M72423701152 | K971480 | 000 |
| M724700151 | K971480 | 000 |
| M724700201 | K971480 | 000 |
| M724700301 | K971480 | 000 |
| M724700401 | K971480 | 000 |
| M724700501 | K971480 | 000 |
| M724700601 | K971480 | 000 |
| M724701151 | K971480 | 000 |
| M724701501 | K971480 | 000 |
| M724701601 | K971480 | 000 |
| M724SL0617401 | K971480 | 000 |
| M724700071 | K971480 | 000 |
| M724700051 | K971480 | 000 |
| M72423701202 | K971480 | 000 |
| M72423701402 | K971480 | 000 |
| M724600151 | K971480 | 000 |
| M724600401 | K971480 | 000 |
| M724600501 | K971480 | 000 |
| M724600601 | K971480 | 000 |
| M724601101 | K971480 | 000 |
| M724601151 | K971480 | 000 |
| M724601201 | K971480 | 000 |
| M724601501 | K971480 | 000 |
| M724SL1217401 | K971480 | 000 |