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510(k) K901375

GRASP (GRIGG-RUSSEL AIR SUPPORT PILLOW) by Medical Plastics Laboratory, Inc. — Product Code INW

K901375 is an FDA 510(k) premarket notification submitted by Medical Plastics Laboratory, Inc. for the device "GRASP (GRIGG-RUSSEL AIR SUPPORT PILLOW)". The FDA issued a decision of Substantially Equivalent on April 19, 1990. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1990
Date Received
March 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type

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  • K940238 — TUMBLE FORMS JUNIOR TRISTANDER (March 7, 1994)
  • K932233 — ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (July 22, 1993)
  • K932238 — ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS (July 22, 1993)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)

FDA data resources