510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790554Substantially Equivalent

Exeter Lip Seal

Exeter Medical Labs, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790554 is the FDA 510(k) clearance record for EXETER LIP SEAL, cleared for Exeter Medical Labs, Inc. on under FDA product code LFA (Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)). FDA records list 2 510(k) clearances for Exeter Medical Labs, Inc., from to . As of , FDA records show no recalls naming K790554.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LFA Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
Device class
Unclassified
Review panel
Unknown
Applicant
Exeter Medical Labs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LFA

Trailing 12 months

FDA records hold no clearances under product code LFA in the trailing twelve months.

FDA records show no clearances under product code LFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260