Core Prevent Mattress Modification
FDA 510(k) K935220 · Paladin Medical, Inc.
510(k) numberK935220
Submission
- Device name
- Core Prevent Mattress Modification
- Applicant
- Paladin Medical, Inc.
Stillwater, MN, US - Received
- October 12, 1993
- Decision date
- November 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMW – Cover, Mattress (Medical Purposes)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6190
- Specialty
- General Hospital
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| K924807 | Reusable Incontient UnderpadFMW · Traditional | Perfect Fit Industries, Inc. | 02/10/1993SE |
| K924477 | Wipeable PillowFMW · Traditional | Perfect Fit Industries, Inc. | 01/29/1993SE |
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| K921928 | Soft-CoverFMW · Traditional | Adroit Medical Systems, Inc. | 11/06/1992SE |
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| K921015 | Sharpe Endosponge AspiiratorHET · Traditional | 05/21/1993SE |
| K915743 | Sharpe EndotenaculumHET · Traditional | 05/20/1993SE |
| K921888 | Sharpe EndodissectorHET · Traditional | 10/20/1992SE |
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Questions and answers
When was Core Prevent Mattress Modification cleared by the FDA?
Core Prevent Mattress Modification (K935220) received a 510(k) decision of Substantially Equivalent on November 29, 1993, 48 days after the submission was received.
What is the product code of K935220?
The FDA product code is FMW – Cover, Mattress (Medical Purposes), a Class I (low risk) device regulated under 21 CFR 880.6190.