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510(k) K830349

SAC-RO-FORM INSERT & BINDER by Deip Enterprises, Inc.

K830349 is an FDA 510(k) premarket notification submitted by Deip Enterprises, Inc. for the device "SAC-RO-FORM INSERT & BINDER". The FDA issued a decision of Substantially Equivalent on March 9, 1983. Deip Enterprises, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
February 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Deip Enterprises, Inc.

  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)
  • K830350 — CERVICAL PILLOW (March 9, 1983)

FDA data resources