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510(k) K790549

HEATING BLOCK, WAMPOLE 37 C by Armkel, LLC — Product Code JRG

K790549 is an FDA 510(k) premarket notification submitted by Armkel, LLC for the device "HEATING BLOCK, WAMPOLE 37 C". The FDA issued a decision of Substantially Equivalent on May 3, 1979. The device falls under product code JRG (Block, Heating), a Class I device regulated under 21 CFR 862.2050. Armkel, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1979
Date Received
March 20, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Heating
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Armkel, LLC

  • K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST (October 19, 2004)
  • K030258 — FIRST RESPONSE PREGNANCY TEST (February 25, 2003)
  • K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS (December 16, 2002)
  • K013433 — TROJAN PASSION BERRY GEL (March 5, 2002)
  • K013614 — TROJAN CRYSTAL CLEAR LIQUID (February 1, 2002)
  • K001212 — TROJAN EXTRA LARGE LATEX CONDOM (May 9, 2000)
  • K000748 — TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT (April 6, 2000)
  • K992232 — FIRST RESPONSE 1-STEP PREGNANCY (December 21, 1999)
  • K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST (October 27, 1997)
  • K973352 — BRAND NAME *1-STEP PREGNANCY (October 27, 1997)

Other clearances for product code JRG

  • K823766 — BLOOD GAS INCUBATOR #260650 (February 18, 1983)
  • K781501 — ENZAC INCUBATOR (October 3, 1978)

FDA data resources