510(k) K875227
- Device
- STERILE EMPTY VIALS
- Applicant
- ALLERTECH, INC.
- 510(k) number
- K875227
- Product code
- LDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-04
- Date received
- 1987-12-22
- 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
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH MCQUADE
- Address
- 7800 S. Elati Littleton CO US 80120 80120
FDA Registration Numbers#
- 2032792
- 3043650518
- 3011050560
- 3030582179
- 1047843
- 3013428737
- 3017896194
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