The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Wyman Suture Washer.
| Device ID | K910186 |
| 510k Number | K910186 |
| Device Name: | WYMAN SUTURE WASHER |
| Classification | Washer, Bolt Nut |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Randall Huebner |
| Correspondent | Randall Huebner ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554017618 | K910186 | 000 |
| 00885554017595 | K910186 | 000 |