Home / 510(k) Clearances / K914615

510(k) K914615

BTP(TM) CENTRALINE(TM) SUIT by Btp Industries, Inc. — Product Code FXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1992
Date Received
October 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suit, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances for product code FXO

  • K891212 — APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE (April 14, 1989)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K865022 — SURGICAL GARMENTS (January 12, 1987)
  • K831207 — SPUNGUARD SCRUB SUIT (May 16, 1983)
  • K822483 — MULTIPLE SCRUB SUIT (September 17, 1982)