The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for External Mechanical Fastener.
| Device ID | K854068 |
| 510k Number | K854068 |
| Device Name: | EXTERNAL MECHANICAL FASTENER |
| 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 | WELLS JOHNSON CO. 2045 NO. FORBES BLVD., STE.106 Tucson, AZ 85745 |
| Contact | John Johnson |
| Correspondent | John Johnson WELLS JOHNSON CO. 2045 NO. FORBES BLVD., STE.106 Tucson, AZ 85745 |
| 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 | 1985-10-04 |
| Decision Date | 1985-11-22 |