The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Anatomical Nasal Implants.
| Device ID | K971481 |
| 510k Number | K971481 |
| Device Name: | DURALASTIC ANATOMICAL NASAL IMPLANTS |
| Classification | Prosthesis, Nose, Internal |
| 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 | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724N91 | K971481 | 000 |
| M724N8NS1 | K971481 | 000 |
| M724N7NS1 | K971481 | 000 |
| M724N6NS1 | K971481 | 000 |
| M724N5NS1 | K971481 | 000 |
| M724N4NS1 | K971481 | 000 |
| M724N3NS1 | K971481 | 000 |
| M724N2NS1 | K971481 | 000 |
| M724N1NS1 | K971481 | 000 |
| M724N129NS1 | K971481 | 000 |
| M724N127NS1 | K971481 | 000 |
| M724N9NS1 | K971481 | 000 |
| M724N11 | K971481 | 000 |
| M724N81 | K971481 | 000 |
| M724N61 | K971481 | 000 |
| M724N51 | K971481 | 000 |
| M724N31 | K971481 | 000 |
| M724N21 | K971481 | 000 |
| M724N1291 | K971481 | 000 |
| M724N1211 | K971481 | 000 |
| M724N71 | K971481 | 000 |
| M724N41 | K971481 | 000 |
| M724N1271 | K971481 | 000 |
| M724N121NS1 | K971481 | 000 |