The following data is part of a premarket notification filed by M-pact Worldwide Management Corp. with the FDA for Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80cc, Ivalon Eye Drain, 400cc, Ivalon Eye Wick.
| Device ID | K971832 |
| 510k Number | K971832 |
| Device Name: | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK |
| Classification | Sponge, Ophthalmic |
| 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 | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-07-31 |
| Summary: | summary |