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510(k) K811750

MULTITUBULAR THORACIC AIR SPLINTS by Roger Cestac & Assoc. — Product Code IPT

K811750 is an FDA 510(k) premarket notification submitted by Roger Cestac & Assoc. for the device "MULTITUBULAR THORACIC AIR SPLINTS". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code IPT (Orthosis, Thoracic), a Class I device regulated under 21 CFR 890.3490. Roger Cestac & Assoc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
June 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Thoracic
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Roger Cestac & Assoc.

  • K811704 — MULTITUBULAR AIR SPLINT KIT (July 1, 1981)

Other clearances for product code IPT

  • K963091 — VOLLMAN PRONE POSITIONER (January 9, 1997)
  • K821645 — BACK SKPPORTS (June 11, 1982)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K761128 — LATERAL TRUNK SUPPORTS (December 2, 1976)

FDA data resources