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510(k) K873949

RORERTAZZI NASOPHARYNGEAL AIRWAY by Penn Medical Devices, Inc. — Product Code BTQ

K873949 is an FDA 510(k) premarket notification submitted by Penn Medical Devices, Inc. for the device "RORERTAZZI NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Penn Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1987
Date Received
September 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Nasopharyngeal
Device Class
Class I
Regulation Number
868.5100
Review Panel
AN
Submission Type

Other clearances by Penn Medical Devices, Inc.

  • K873176 — HUFFMAN BIOPSY UNIT (October 14, 1987)
  • K873177 — DEVINE (SUPRAPUBIC SOUND AND GUIDE) (October 14, 1987)
  • K873178 — URETERAL BULB DILATORS (September 30, 1987)
  • K871667 — URETERAL STENT (June 10, 1987)
  • K870508 — GASTROINTESTINAL TUBE (May 11, 1987)
  • K862729 — PENN 3-RING HANDLE (October 24, 1986)
  • K862107 — PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR (September 11, 1986)

Other clearances for product code BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K901279 — CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (March 28, 1990)
  • K883668 — SUNDERLAND NASAL TUBE (November 21, 1988)
  • K871673 — NASOPHARYNGEAL AIRWAY (June 15, 1987)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

FDA data resources