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510(k) K780391

PODIATRIC MATERIAL by Crown Delta Corp. — Product Code MNE

K780391 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "PODIATRIC MATERIAL". The FDA issued a decision of Substantially Equivalent on June 14, 1978. The device falls under product code MNE (Orthosis, Moldable, Supportive, Skin Protective), a Class I device regulated under 21 CFR 890.3475. Crown Delta Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1978
Date Received
March 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Moldable, Supportive, Skin Protective
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Crown Delta Corp.

  • K122974 — TRYOUT-VPS HOLDING PASTE (May 17, 2013)
  • K041028 — CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL (May 14, 2004)
  • K955288 — HEARING AID IMPRESSION MATERIAL (February 2, 1996)
  • K940132 — PODIATRIC MATERIAL (September 29, 1994)
  • K930248 — VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM (January 7, 1994)
  • K926150 — VINYL ADDITION SILICONE SYSTEM (July 14, 1993)
  • K901990 — VINYL SILICONE ELASTOMER MATERIAL (September 14, 1990)
  • K901991 — SILICONE ELASTOMER PUTTY (September 14, 1990)
  • K872745 — VINYL POLYSILOXANE IMPRESSION SYSTEM (July 21, 1987)
  • K871409 — VINYL POLYSILOXANE IMPRESSION SYSTEM (June 11, 1987)

Other clearances for product code MNE

  • K940132 — PODIATRIC MATERIAL (September 29, 1994)

FDA data resources