510(k) K922177
- Device
- DISPOSABLE MULTI-PUNCTURE APPLICATOR
- Applicant
- ALLERGY EXTRACT CO.
- 510(k) number
- K922177
- Product code
- LDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-06-17
- Date received
- 1992-05-08
- Regulation
- 510(k) Premarket Notification
- Classification name
- System, Delivery, Allergen And Vaccine
- 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
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BALDWIN
- Address
- Mill Run Professional Parke 3760 Ridge Mill Dr. Hilliard OH US 43026 43026
FDA Registration Numbers#
- 3007590959
- 3009449769
- 3002807310
- 3011088743
- 1011574
- 3015536286
- 1424263
- 8043734
- 3014290918
- 3008812251
- 1061927
- 3010131789
- 3010132111
- 3030554525
- 1047843
- 2248704
- 3017896194
- 1055876
- 2531321
- 1450391
- 1928237
- 3012620142
- 1423507
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases