The following data is part of a premarket notification filed by Omnicon Medical Corp. with the FDA for Protect Iv Gard.
| Device ID | K772060 |
| 510k Number | K772060 |
| Device Name: | PROTECT IV GARD |
| Classification | Protector, Skin Pressure |
| Applicant | OMNICON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMP |
| CFR Regulation Number | 880.6450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-31 |
| Decision Date | 1977-12-20 |