510(k) K872230
- Device
- MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
- Applicant
- INTERMEDICS, INC.
- 510(k) number
- K872230
- Product code
- DBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-15
- Date received
- 1987-06-09
- Regulation
- 866.5330
- Classification name
- Factor Xiii A, S, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN BISHOP
- Address
- P.O. Box 617 Freeport TX US 77541 77541
FDA Registration Numbers#
- 2084025
- 1217183
- 9610746
- 3037000637
- 3011059082
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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