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510(k) K893452

EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM by Warner-Lambert Co. — Product Code IZZ

K893452 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
May 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Non-Tilting, Powered
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Warner-Lambert Co.

  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K870584 — O.P.T.(TM) OVULATION PREDICTION TEST (November 25, 1987)
  • K861510 — MULTILUMEN VIAPIC CENTRAL LINE CATHETER (June 9, 1986)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (August 19, 1985)
  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K852889 — GENERAL DIAGNOSTICS RAPID E. COLI TEST (July 23, 1985)
  • K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (May 8, 1985)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)
  • K850409 — GEN. DIAG. CHROMOSTRATE REF. PLASMA (May 8, 1985)

Other clearances for product code IZZ

  • K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (May 14, 1997)
  • K952701 — MED-TRON SPECT IMAGING TABLE (July 6, 1995)
  • K951315 — CATHETERIZATION TABLE KS-60 (May 11, 1995)
  • K951053 — ANGIOREX CAT-350B (April 6, 1995)
  • K943926 — RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (November 28, 1994)
  • K930273 — ALPHA (July 13, 1993)
  • K924444 — B-4 FOUR-WAY RADIOGRAPHIC TABLE (February 5, 1993)
  • K925174 — SHIMADZU RADIOGRAPHIC TABLE BK-100 (November 27, 1992)
  • K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (May 15, 1992)
  • K920732 — CATHERIZATION KS-50 (April 16, 1992)

FDA data resources