510(k) K932636
- Device
- THE TUCKER SLING
- Applicant
- TUCKER DESIGNS, LTD.
- 510(k) number
- K932636
- Product code
- FRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-26
- Date received
- 1993-06-02
- Regulation
- 880.5680
- Classification name
- Holder, Infant Position
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEITH A JARRETT,JR.
- Address
- P.O. Box 641117 Kenner LA US 70064 70064
FDA Registration Numbers#
- 3000279201
- 3007842980
- 3006450239
- 2319127
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082367 | INFANT SLEEP BEANIE | Life Innovations, LLC | 2009-06-12 |
| K090284 | RES-Q INFANT WEDGE AND SLING | Cr Enterprises, LLC | 2009-06-05 |
| K062143 | KOZY COMFORT INFANT POSITIONER | Alfred E Mann Inst. For Biomedical Engineering | 2006-10-24 |
| K060986 | HEAD BED | Steven H. Warnock, M.D. | 2006-07-11 |
| K051300 | ROBIN HOOD VEST | Kamber Corporation | 2005-12-08 |
| K041996 | NIGHTFORM | Plastic Surgery Solutions, LLC | 2004-08-03 |
| K003511 | KENDALL-LTP TURNER SAVE-A-LINE | The Ludlow Company LP | 2001-01-24 |
| K943017 | NEONATAL RESTRAINT AND COMFORT SYSTEMS | K.Bowmed, Inc. | 1995-01-19 |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | Pedicraft, Inc. | 1991-03-13 |
| K905630 | INFANT REFLUX SLING | Pedicraft, Inc. | 1991-03-13 |
| K882544 | CUDDLE UP PILLOW | Ohio Medical Instrument Co., Inc. | 1989-01-31 |
| K844176 | PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS | Premie Comfort Products | 1985-01-23 |
| K810609 | PEDIATRIC POSITION HOLDER | Kaye Products, Inc. | 1981-03-20 |
Legacy Summary#
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FDA Review#
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