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510(k) K931819

CARAPACE SUTURE REMOVAL TRAYS by Carapace, Inc. — Product Code IRO

K931819 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "CARAPACE SUTURE REMOVAL TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 26, 1994. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Carapace, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 26, 1994
Date Received
April 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vibrator, Therapeutic
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type

Other clearances by Carapace, Inc.

  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
  • K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
  • K931729 — I.V. START KIT (February 22, 1994)
  • K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
  • K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
  • K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)
  • K931670 — CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (January 25, 1994)

Other clearances for product code IRO

  • K955250 — QI GONG MASSAGER (February 8, 1996)
  • K955160 — COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (February 8, 1996)
  • K954203 — MASSAGER THERAPUTIC, ELECTRIC (December 11, 1995)
  • K952916 — SHIATSU MASTER MASSAGER CUSHION (August 28, 1995)
  • K951414 — CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (August 11, 1995)
  • K950441 — CONAIR FAMILY FITNESS BODY ENERGY (July 18, 1995)
  • K946382 — SKALPI 3200 (May 30, 1995)
  • K950410 — CONAIR BODY AND SOLE (May 23, 1995)
  • K944909 — WAHL FRESH FACE (May 8, 1995)
  • K950400 — HAND MASSAGE UNIT (March 30, 1995)

FDA data resources