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510(k) K830993

AMPLIGREFFE by Prothia USA, Inc. — Product Code GFD

K830993 is an FDA 510(k) premarket notification submitted by Prothia USA, Inc. for the device "AMPLIGREFFE". The FDA issued a decision of Substantially Equivalent on May 3, 1983. The device falls under product code GFD (Dermatome), a Class I device regulated under 21 CFR 878.4820. Prothia USA, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1983
Date Received
March 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dermatome
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Prothia USA, Inc.

  • K831071 — UNIVERSAL INSTRU. SET FOR NEUROVASCULAR (June 8, 1983)
  • K823581 — ELPHA 500 (March 24, 1983)
  • K830058 — MYOGRAPH 2000 (March 7, 1983)
  • K823583 — MYOTEST NERVE STIMULATOR (December 30, 1982)

Other clearances for product code GFD

  • K965256 — DMS-1000C DERMOABRADER (December 9, 1996)
  • K962371 — DERMTOME BLADE (August 29, 1996)
  • K945594 — DECA DERMATOME (MICROMOTOR SYSTEM) (June 5, 1995)
  • K951085 — PADGETT AIR DERMATOME, MODEL A (May 15, 1995)
  • K940208 — AESCULAP ACCU-DERMATOME (February 24, 1994)
  • K862669 — ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (October 3, 1986)
  • K861285 — SKIN MESH DEVICE (April 17, 1986)
  • K861138 — MASH DERMATOME (April 14, 1986)
  • K860925 — DERMASPANDERE (March 28, 1986)
  • K842702 — ROSENBERG SKIN GRAFTING KNIVES (August 2, 1984)

FDA data resources