510(k) K882618
K882618 is an FDA 510(k) premarket notification submitted by Gamut Ent. for the device "JEDMED/POLACK KERATOSCOPE HS/SL". The FDA issued a decision of Substantially Equivalent on July 13, 1988. The device falls under product code HLR (Keratoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1988
- Date Received
- June 24, 1988
- 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