The following data is part of a premarket notification filed by Acme-monaco Corp. with the FDA for Guidewires, Various Types.
| Device ID | K920884 |
| 510k Number | K920884 |
| Device Name: | GUIDEWIRES, VARIOUS TYPES |
| Classification | Wire, Guide, Catheter |
| Applicant | ACME-MONACO CORP. 26468 ASBURY AVE. Crisfield, MD 21817 |
| Contact | Herbert Carter |
| Correspondent | Herbert Carter ACME-MONACO CORP. 26468 ASBURY AVE. Crisfield, MD 21817 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-02 |
| Decision Date | 1992-08-19 |