510(k) K903544
- Device
- CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
- Applicant
- J.J. SKINNER, INC.
- 510(k) number
- K903544
- Product code
- LRP
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 1990-08-31
- Date received
- 1990-08-06
- 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
- ALAN P SCHWARTZ
- Address
- C/O Medical Device Inspection 55 Northern Blvd., Suite 301 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 9611503
- 3010376936
- 3004122598
- 9615270
- 9710524
- 3007773213
- 3013247477
- 3015991317
- 3004519921
- 8040881
- 1030489
- 1222780
- 3013011598
- 2529846
- 3002808270
- 3005182241
- 1422634
- 1420054
- 3006215390
- 1048735
- 3043164947
- 3012944064
- 3000199132
- 3025905693
- 3009417901
- 3027847726
- 3003418325
- 1314417
- 9680244
- 3003877407
- 3016170492
- 1422507
- 3012429289
- 3031240334
- 3013358456
- 9616088
- 2424366
- 3015168527
- 3001084743
- 3014314985
- 3035678069
- 3027320022
- 1221053
- 3010726901
- 3000270450
- 2242656
- 2249529
- 3005809810
- 2029015
- 2027062
- 1043572
- 3008902714
- 3007494564
- 3005108347
- 3010452421
- 3010829427
- 3007137643
- 3026057410
- 9681599
- 3008323540
- 3045857302
- 1043214
- 2183785
- 1018470
- 2126376
- 1066741
- 1047429
- 1123010
- 1649390
- 3011767135
- 3008559312
- 3009888344
- 3009540749
- 3036002406
- 2084346
- 3008747271
- 3002834291
- 3038632739
- 1646747
- 3006210673
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 |
| 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 |
| 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