510(k) K903963
- Device
- KITS AND TRAYS FOR ONE TIME USE ONLY
- Applicant
- APK TECHNOLOGY
- 510(k) number
- K903963
- Product code
- LRP
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1991-07-29
- Date received
- 1990-08-28
- Regulation
- 878.4800
- Classification name
- Tray, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMIR PORAT
- Address
- Pob 6462 Ganei Yehuda Israel IL 56905 56905
FDA Registration Numbers#
- 3011301313
- 3010864832
- 1417592
- 3017410889
- 3011749806
- 3013247477
- 1650372
- 3012104006
- 3010039499
- 1314417
- 3010097171
- 1834331
- 3010041511
- 3004111573
- 9611062
- 3005669815
- 3007539489
- 3012944064
- 3012447612
- 1820334
- 1412854
- 3006636962
- 3004122598
- 9613079
- 3032747418
- 1000124971
- 3025663209
- 1030489
- 3009140376
- 3011371465
- 2000028362
- 3009465247
- 3024706750
- 1643817
- 3024988980
- 3014644369
- 9611367
- 3043164947
- 1048735
- 1836161
- 3002862271
- 3007494564
- 3014257280
- 1056350
- 3008773560
- 1450662
- 3006128100
- 3015351976
- 3010235355
- 9710524
- 3009110133
- 2242056
- 3009158523
- 3009165919
- 9681622
- 9610773
- 1824619
- 1825034
- 9680357
- 3009887475
- 1123137
- 1935627
- 3009756153
- 3035678069
- 3025905693
- 3001084743
- 8030607
- 3000270450
- 3008902714
- 3001650535
- 3022320321
- 3005467144
- 9610612
- 3008346537
- 3011526299
- 1037577
- 1057404
- 1646747
- 3008392711
- 3005528784
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963723 | LACERATION TRAY | Grand Medical Products | 1996-11-27 |
| K951811 | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | Osteotech, Inc. | 1995-05-31 |
| K940239 | EYE TRAY | Cush Medical Products | 1994-06-28 |
| K935621 | CUSTOM ENT PACKS | Associated Medical | 1994-03-30 |
| K940646 | ORTHOPEDIC TRAY PRODUCT LINE | Cushindu | 1994-03-11 |
| K940444 | GENERAL SURGERY TRAY | Cush Medical Products | 1994-03-07 |
| K922126 | HOSPITAL KIT ENT 1125 | Savoy Medical Supply Co., Inc. | 1993-01-21 |
| K912105 | EYE TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 |
| K903962 | INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE | Apk Technology | 1991-07-29 |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | Angiosystems, Inc. | 1991-02-06 |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | J.J. Skinner, Inc. | 1990-08-31 |
| K890071 | STERILE LACERATION TRAY | Mumtaz I. Malik | 1989-01-24 |
| K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1988-08-18 |
| K882275 | STERILE PACK (PROCEDURAL TRAY/KITS) | East Texas Lighthouse For the Blind | 1988-07-18 |
| K881095 | KOI(TM) INSTRUMENT TRAYS | CooperVision, Inc. | 1988-04-06 |
Legacy Summary#
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FDA Review#
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