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510(k) K852345

SEA-LONG NECKSEAL & HOOD by Safety Sea Systems, Inc. — Product Code BYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1985
Date Received
May 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tent, Oxygen
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
Submission Type

Other clearances for product code BYL

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  • K905627 — NASCOR OXYDOME (June 3, 1991)
  • K896608 — SPAG PAK (April 9, 1990)
  • K895866 — DIRD INGANT O2 (BIO 2 HOOD) (October 27, 1989)
  • K893713 — NOVA OXYGEN TENT (August 21, 1989)
  • K893714 — KEYSTONE OXYGEN TENT (August 21, 1989)
  • K882396 — AEROSOL DELIVERY HOOD (August 1, 1988)
  • K851666 — MEDI-COMP NEONATAL OXYGEN HOOD (August 6, 1985)
  • K820640 — HOO2D SEAT-INFANT (March 26, 1982)
  • K802653 — MEDIUM SIZE OXYGEN HOOD #1547 (November 24, 1980)