510(k) K962032
K962032 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ TWIN TRANSILLUMINATOR". The FDA issued a decision of Substantially Equivalent on July 5, 1996. The device falls under product code MQW (Transilluminator, Fiber Optic), a Class I device regulated under 21 CFR 874.4350. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 1996
- Date Received
- May 24, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transilluminator, Fiber Optic
- Device Class
- Class I
- Regulation Number
- 874.4350
- Review Panel
- EN
- Submission Type