510(k) K033593
- Device
- REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
- Applicant
- Clearmedical, Inc.
- 510(k) number
- K033593
- Product code
- NLU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-20
- Date received
- 2003-11-13
- Regulation
- 876.4300
- Classification name
- Forceps, Biopsy, Electric, Reprocessed
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- MIKE KOVACS
- Address
- 1776 136th Pl. NE Bellevue WA US 98005 98005
FDA Registration Numbers#
- 3032391
- 1061124
- 2011171
- 1018470
- 3011024991
Source Documents#
Other 510(k) Records For Product Code NLU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050136 | REPROCESSED HOT BIOPSY FORCEPS | Sterilmed, Inc. | 2005-07-20 |
| K024011 | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES | Surgical Instruments Service and Savings, Inc. | 2002-12-19 |
| K011800 | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | Vanguard Medical Concepts, Inc. | 2001-09-27 |