The following data is part of a premarket notification filed by M-pact Worldwide Management Corp. with the FDA for Ivalon Instrument Wipe, Ivalon Knife Cleaning Block.
| Device ID | K971473 |
| 510k Number | K971473 |
| Device Name: | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | M-PACT WORLDWIDE MANAGEMENT CORP. 1040 O.C.L. PKWY. INTECH BUSINESS PK. Eudora, KS 66025 |
| Contact | Barry Hale |
| Correspondent | Barry Hale M-PACT WORLDWIDE MANAGEMENT CORP. 1040 O.C.L. PKWY. INTECH BUSINESS PK. Eudora, KS 66025 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-07-07 |