510(k) K901309
K901309 is an FDA 510(k) premarket notification submitted by Sylvan Corp. for the device "SYLVAN PEDIASCAN 200 TRANSILLUMINATOR". The FDA issued a decision of Substantially Equivalent on May 24, 1990. The device falls under product code HJN (Transilluminator, Battery-Powered), a Class I device regulated under 21 CFR 886.1945.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1990
- Date Received
- March 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transilluminator, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1945
- Review Panel
- OP
- Submission Type