510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923652Substantially Equivalent

Dulbecco's Phosphate Buffered Saline

Life-Tech Intl., Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923652 is the FDA 510(k) clearance record for DULBECCO'S PHOSPHATE BUFFERED SALINE, a class II device, cleared for Life-Tech Intl., Inc. on under FDA product code MFD (Cannula, Intrauterine Insemination). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K923652.

Clearance record

Decision date
Received
(413 days to decision)
Product code
MFD Cannula, Intrauterine Insemination
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Life-Tech Intl., Inc. P.O. Box 36221, Houston TX
510(k) summary
Summary
Third party review
No

Clearances, product code MFD

Trailing 12 months

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

FDA records show no clearances under product code MFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MFD, 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