510(k) K903962
- Device
- INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE
- Applicant
- APK TECHNOLOGY
- 510(k) number
- K903962
- 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#
- 3005440795
- 2249529
- 3009465247
- 3004521401
- 3009420946
- 3021023132
- 3002675176
- 3027305775
- 3022320321
- 9680244
- 1061124
- 1066741
- 3006191977
- 3013358456
- 3009255580
- 1820334
- 1056350
- 3009888344
- 3014908171
- 3004122598
- 3005467144
- 9610773
- 8043816
- 3007494564
- 3013602181
- 8031020
- 3005031160
- 1057404
- 3042989733
- 3009538923
- 9710524
- 3003924117
- 3012429289
- 2126376
- 1030489
- 1032347
- 3038613790
- 3004519921
- 1043572
- 3005528784
- 1527736
- 9611503
- 3010622588
- 8040233
- 1834331
- 1834379
- 3002862271
- 3013247477
- 3006210673
- 3005182241
- 9616088
- 3024706750
- 1721686
- 3010598169
- 1043534
- 3010453282
- 3012421607
- 9680909
- 9681622
- 1221053
- 3010452421
- 3014644369
- 3010583458
- 8030607
- 8030673
- 3005625540
- 9611062
- 3005641619
- 1123010
- 3000270450
- 3016171961
- 9680168
- 3006636962
- 3006554788
- 9710629
- 3004551550
- 3002834291
- 3009165919
- 3003032798
- 8040881
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 |
| K903963 | KITS AND TRAYS FOR ONE TIME USE ONLY | 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases