The following data is part of a premarket notification filed by Acme-monaco Corp. with the FDA for Acme Guidewires For Percutaneous Insertion Of Cath.
| Device ID | K883763 |
| 510k Number | K883763 |
| Device Name: | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH |
| Classification | Catheter, Urological |
| Applicant | ACME-MONACO CORP. P.O. BOX 264 Plainville, CT 06052 |
| Contact | Herbert M Carter |
| Correspondent | Herbert M Carter ACME-MONACO CORP. P.O. BOX 264 Plainville, CT 06052 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-11-18 |