510(k) K901553
K901553 is an FDA 510(k) premarket notification submitted by The Sanborn Co. for the device "SURG-K SURGICAL KERATOMETER". The FDA issued a decision of Substantially Equivalent on Jul 20, 1990. The device falls under product code HLR (Keratoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1350. The Sanborn Co. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 20, 1990
- Date Received
- Apr 3, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Keratoscope, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt