510(k) K850186
- Device
- POST AURICULAR HEARING AIDS STAR 33PP, 44,55F &
- Applicant
- ROBERT BOSCH CORP.
- 510(k) number
- K850186
- 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 &
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-27
- Date received
- 1985-01-18
- Regulation
- 510(k) Premarket Notification
- Classification name
- 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
- Medical specialty
- 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
- Review panel
- Gastroenterology/Urology
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHERYL M LEISTER
- Address
- Flower Field Bldg. #17 Mill Pond Rd. St. James NY US 11780 11780
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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