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510(k) K983043

SEARE BIOMEDICAL SILICONE BLOCK by Seare Biomedical Corp. — Product Code MIC

K983043 is an FDA 510(k) premarket notification submitted by Seare Biomedical Corp. for the device "SEARE BIOMEDICAL SILICONE BLOCK". The FDA issued a decision of Substantially Equivalent on September 30, 1998. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. Seare Biomedical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
August 31, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Muscle, Pectoralis
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

Other clearances by Seare Biomedical Corp.

  • K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (December 11, 1998)
  • K983630 — SEARE BIOMEDICAL SILICONE RODS (December 11, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K983041 — SEARE BIOMEDICAL SILICONE SHEETING (September 30, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
  • K982752 — SEARE BIOMEDICAL CHIN IMPLANTS (September 30, 1998)

Other clearances for product code MIC

  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K944163 — SPECTRUM DISIGNS PECTORAL IMPLANT (November 7, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)

FDA data resources