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510(k) K952203

OTOSILK by Boston Medical Products, Inc. — Product Code NAD

K952203 is an FDA 510(k) premarket notification submitted by Boston Medical Products, Inc. for the device "OTOSILK". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Boston Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
May 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Boston Medical Products, Inc.

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • K972317 — MONTGOMERY THYROPLASTY IMPLANT SYSTEM (September 18, 1997)
  • K972459 — RHINOCELL NASAL PACKINGS (August 4, 1997)
  • K972096 — BIVALVE NASAL SPLINT (July 15, 1997)
  • K972078 — POST-STOP EPISTAXIS CATHETER (July 10, 1997)
  • K972092 — NASAL AIRWAY SPLINT (July 8, 1997)
  • K972151 — DOYLE COMBO NASAL AIRWAY SPLINT (July 7, 1997)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972077 — EPI-STOP EPISTAXIS CATHETER (June 26, 1997)

Other clearances for product code NAD

  • K254246 — LT Antibacterial Foam with Silver Dressing (September 10, 2026)
  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)

FDA data resources