510(k) K771725
- Device
- BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.
- Applicant
- Xomed, Inc.
- 510(k) number
- K771725
- Product code
- FEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-26
- Date received
- 1977-09-13
- Regulation
- 876.5090
- Classification name
- Instrument, Catheter, Punch
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 1318 Lonedell Rd. Arnold MO US 63010 63010
FDA Registration Numbers#
- 8030607
- 9613926
- 1836161
- 3001644167
- 1820334
- 8040278
- 3009688853
- 1825146
- 9611112
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911104 | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 | Hgm Medical Laser Systems, Inc. | 1991-06-11 |