510(k) K963391
- Device
- SPECULITE
- Applicant
- TRYLON CORP.
- 510(k) number
- K963391
- Product code
- MPU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-12
- Date received
- 1996-08-28
- Regulation
- 884.4530
- Classification name
- Source, Chemiluminescent Light
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- A. THOMAS DOYLE
- Address
- 23268 Atlantis Way Monarch Beach CA US 92629 92629
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MPU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K012070 | ORALLITE COMPREHENSIVE EXAM TRAY | Trylon Corp. | 2001-11-27 |
Legacy Summary#
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FDA Review#
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