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510(k) K884357

PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM by Precision Dynamics Corp. — Product Code KOT

K884357 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 1, 1988. The device falls under product code KOT (Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium), a Class I device regulated under 21 CFR 872.3490. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1988
Date Received
October 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Device Class
Class I
Regulation Number
872.3490
Review Panel
DE
Submission Type

Other clearances by Precision Dynamics Corp.

  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (March 22, 2000)
  • K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (January 24, 2000)
  • K990737 — 'ECURLINE UMBILICAL CORD CLAMP #3500 (April 6, 1999)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)
  • K874665 — SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (January 20, 1988)
  • K873369 — SECURLINE FRANSEENE NEEDLE (October 20, 1987)
  • K872507 — PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (July 9, 1987)
  • K863164 — AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (August 27, 1986)
  • K851364 — FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP (April 22, 1985)

Other clearances for product code KOT

  • K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM (December 20, 1994)
  • K941365 — MPI DENTURE ADHESIVE FILM SEALS (April 22, 1994)
  • K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM (October 24, 1990)
  • K895818 — STEADFAST DENTURE ADHESIVE CREAM (April 3, 1990)
  • K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (June 30, 1987)
  • K854430 — RIGIDENT CREAM (March 4, 1986)
  • K831493 — DENTURE ADHESIVE SEALS (June 30, 1983)

FDA data resources