510(k) K950560
- Device
- SALINE SOLUTINE, STERILE
- Applicant
- BUSSE HOSPITAL DISPOSABLES, INC.
- 510(k) number
- K950560
- Product code
- IGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-30
- Date received
- 1995-02-08
- Regulation
- 864.4010
- Classification name
- Solution, Formalin Ammonium Bromide
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- EILEEN RAMA
- Address
- P.O. Box 11067 Hauppauge NY US 11788 11788
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842862 | CB FORMALIN | Anatech, Ltd. | 1984-08-28 |
Legacy Summary#
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FDA Review#
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