The following data is part of a premarket notification filed by Acutek Adhesive Specialties, Inc. with the FDA for Acutek's Clearpassage.
| Device ID | K951644 |
| 510k Number | K951644 |
| Device Name: | ACUTEK'S CLEARPASSAGE |
| Classification | Dilator, Nasal |
| Applicant | ACUTEK ADHESIVE SPECIALTIES, INC. 540 NORTH OAK ST. Inglewood, CA 90302 |
| Contact | Greg Holland |
| Correspondent | Greg Holland ACUTEK ADHESIVE SPECIALTIES, INC. 540 NORTH OAK ST. Inglewood, CA 90302 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-07-03 |