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510(k) K842472

DRYDEN INFLATABLE MASK by Dryden Corp. — Product Code BSJ

K842472 is an FDA 510(k) premarket notification submitted by Dryden Corp. for the device "DRYDEN INFLATABLE MASK". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Dryden Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
June 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
Review Panel
AN
Submission Type

Other clearances by Dryden Corp.

  • K880923 — PATIENT VENTILATOR ISOLATOR (September 6, 1988)
  • K880769 — BREATHING CIRCUIT W/HEATED WIRE (August 24, 1988)
  • K882285 — NONREBREATHING CIRCUIT (August 16, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K873927 — REUSEABLE BREATHING TUBES (October 20, 1987)
  • K870859 — BAG-TAIL BLEED VALVE (August 3, 1987)
  • K871386 — BREATHING CIRCUIT (May 29, 1987)
  • K870858 — BADGWELL SAMPLING CATHETER (May 14, 1987)
  • K861540 — DISPOSABLE BERMAN AND GUEDEL AIRWAYS (May 2, 1986)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)

FDA data resources