The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Homer Mammalok Localization Shield.
| Device ID | K885090 |
| 510k Number | K885090 |
| Device Name: | HOMER MAMMALOK LOCALIZATION SHIELD |
| Classification | General Surgery Tray |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Robert E Franklin |
| Correspondent | Robert E Franklin NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-02-14 |