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510(k) K882618

JEDMED/POLACK KERATOSCOPE HS/SL by Gamut Ent. — Product Code HLR

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 Jul 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
Jul 13, 1988
Date Received
Jun 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
510(k) Exempt

Other clearances for product code HLR

  • K901553 — SURG-K SURGICAL KERATOMETER (Jul 20, 1990)
  • K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE (Aug 4, 1988)
  • K864639 — REUSABLE SURGICAL KERATOSCOPE (Dec 29, 1986)
  • K854054 — PLACIDO DISC (Dec 27, 1985)
  • K830008 — KARICKHOFF KERATOSCOPE (Jan 26, 1983)
  • K821080 — HAND KERATOSCOPE (May 24, 1982)

FDA data resources

Source: FDA 510(k) database entry for K882618. Report a data issue: hello@regdatalab.com.