510(k) K922126
- Device
- HOSPITAL KIT ENT 1125
- Applicant
- SAVOY MEDICAL SUPPLY CO., INC.
- 510(k) number
- K922126
- Product code
- LRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-01-21
- Date received
- 1992-05-06
- Regulation
- 878.4800
- Classification name
- Tray, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GUY SAVIA
- Address
- 99 W. Hawthorne Ave. Valley Stream NY US 11580 11580
FDA Registration Numbers#
- 3006554788
- 3017410889
- 1421879
- 2242656
- 3003924117
- 3006636962
- 3005809810
- 3010303097
- 3002669946
- 9616088
- 3011767135
- 3016659819
- 3031284747
- 1066741
- 3025905693
- 3003322138
- 1222780
- 1000124971
- 1018470
- 3010039499
- 3002862271
- 1045834
- 1037577
- 3008747271
- 5906
- 3042989733
- 3005467144
- 3027305775
- 2184066
- 9615270
- 3009465247
- 3003032798
- 1422507
- 1834379
- 3008936260
- 1043534
- 3007773213
- 3019455
- 3010598169
- 3009584307
- 3035642068
- 3005641619
- 8010890
- 3018167761
- 1823410
- 3013602181
- 2320762
- 1054241
- 3011301313
- 9611503
- 3034676720
- 3007539489
- 3001650535
- 3006215390
- 9681622
- 3022320321
- 1225691
- 3013503739
- 3008489813
- 3010041511
- 3013011598
- 3015173212
- 3006128100
- 3004122598
- 1423537
- 3011371465
- 3005595283
- 1648571
- 3014644369
- 3003120897
- 9613079
- 3000199132
- 3013247477
- 3015276780
- 3007420745
- 3027847726
- 3021023132
- 3011526299
- 3005360851
- 3017896194
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 |
| 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 |
| 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