The following data is part of a premarket notification filed by U.s. Mfg. & Management, Inc. with the FDA for Modified I.v. Start, Re-start, Pedi And Geri-kit.
| Device ID | K862335 |
| 510k Number | K862335 |
| Device Name: | MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT |
| 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 | U.S. MFG. & MANAGEMENT, INC. 287 SOUTH STODDARD AVE. San Bernardino, CA 92401 |
| Contact | Frank J Rauscher |
| Correspondent | Frank J Rauscher U.S. MFG. & MANAGEMENT, INC. 287 SOUTH STODDARD AVE. San Bernardino, CA 92401 |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-19 |
| Decision Date | 1986-07-24 |