510(k) K895885
- Device
- AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING
- Applicant
- NATIONAL-STANDARD CO.
- 510(k) number
- K895885
- Product code
- FCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-09
- Date received
- 1989-10-05
- Regulation
- 876.1075
- Classification name
- Punch, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBINSON
- Address
- 4445-360 SW 35th Ter. Gainesville FL US 32608 32608
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894627 | BT-338N ELECTRONIC CLINICAL THERMOMETER | Integrated Display Technology, Ltd. | 1989-10-23 |
| K875119 | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | Advanced Diagnostic Medical Systems, Inc. | 1988-03-02 |
| K853104 | DISPOSABLE, STERILE BIOPSY PUNCH | August C. Stiefel Research Institute, Inc. | 1985-10-04 |
| K831317 | BIOPSY ATTACHMENT | Diasonics, Inc. | 1983-05-18 |
Legacy Summary#
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FDA Review#
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