The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Sure-count 30 Count Magnetic Needle Counter.
| Device ID | K852258 |
| 510k Number | K852258 |
| Device Name: | SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | KLEEN TEST PRODUCTS 4425 W. WOOLWORTH AVE. P.O.B OX 574 Milwaukee, WI 53218 |
| Contact | Rick W Poenitsch |
| Correspondent | Rick W Poenitsch KLEEN TEST PRODUCTS 4425 W. WOOLWORTH AVE. P.O.B OX 574 Milwaukee, WI 53218 |
| Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-24 |
| Decision Date | 1985-06-27 |