510(k) K960241
- Device
- CPR GENERAL SURGERY TRAY
- Applicant
- CUSTOM PACK RELIABILITY
- 510(k) number
- K960241
- Product code
- LRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-22
- Date received
- 1996-01-16
- Regulation
- 878.4370
- Classification name
- General Surgery Tray
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD L ELLWOOD
- Address
- 4207 Vineland Rd., M-1 Orlando FL US 32811 32811
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213481 | Medline General Surgery Tray | Medline Industries, Inc. | 2022-05-24 |
| K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | 2021-12-03 |
| K041080 | SURGICAL DRAPE KIT - D.I.R.R.A. SRL | D.I.R.R.A. S.R.L. | 2004-11-30 |
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Ballard Medical Products | 2003-03-31 |
| K023276 | AMSINO TRACHEOSTOMY CARE TRAY | Amsino International, Inc. | 2002-12-09 |
| K980137 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY | Worldwide Medical Technologies, LLC | 1998-01-30 |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Opportunity, Inc. | 1997-06-11 |
| K971062 | OPPORTUNITY INC. GENERAL PURPOSE TRAY | Opportunity, Inc. | 1997-06-09 |
| K932221 | NEUROLOGICAL OR CRANI TRAYS (PACKS) | Associated Medical Products Co. | 1997-03-19 |
| K970286 | PRESBYTERIAN LINEN SERVICES SURGICAL PACKS | Medline Industries, Inc. | 1997-03-10 |
| K970187 | RUNYON LARGE VOLUME PARACENTESIS KIT | Gi Supply | 1997-02-14 |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1997-02-14 |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Trinity Laboratories, Inc. | 1997-01-22 |
| K963721 | SKIN SCRUB TRAY | Grand Medical Products | 1996-11-27 |
| K963715 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | Grand Medical Products | 1996-11-27 |
Legacy Summary#
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FDA Review#
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