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510(k) K961087

DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS by Debusk Knitting Mills, Div. Deroyal Industries — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1996
Date Received
March 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Debusk Knitting Mills, Div. Deroyal Industries

  • K961097 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (June 3, 1996)
  • K961085 — DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING (May 21, 1996)
  • K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER (January 11, 1996)

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