510(k) K880253
- Device
- BLAKEMORE RETAINER
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K880253
- Product code
- FEF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-11
- Date received
- 1988-01-20
- Regulation
- 876.5980
- Classification name
- Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT R MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
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