510(k) K883098
- Device
- SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
- Applicant
- SITE MICROSURGICAL SYSTEMS, INC.
- 510(k) number
- K883098
- Product code
- LRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-18
- Date received
- 1988-07-22
- 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
- MCCRACKEN
- Address
- 135 Gibraltar Rd. Horsham PA US 19044 19044
FDA Registration Numbers#
- 1123137
- 3010039499
- 9617297
- 9680909
- 3008323540
- 3003322138
- 3005440795
- 3025107383
- 3005071827
- 3036002406
- 1225691
- 3012429289
- 3004521401
- 3004215117
- 2249529
- 3005595283
- 1650372
- 3005467144
- 1060680
- 1421879
- 1056350
- 1061124
- 1834379
- 3003761012
- 8040278
- 3006636962
- 8010099
- 3010041511
- 3035678069
- 3008559312
- 3007589150
- 2242656
- 3009465247
- 1923569
- 2433012
- 3011767135
- 3009756153
- 9611579
- 3008338766
- 3012251300
- 3007420745
- 1929756
- 3025663209
- 1833824
- 3018167761
- 3015173212
- 1314417
- 8030673
- 3004111573
- 3010235355
- 3005075853
- 8040881
- 9613926
- 3009110133
- 1045834
- 3005031160
- 3013011598
- 1057404
- 3004519921
- 3010399422
- 3031582434
- 3003759558
- 3035858921
- 3016171961
- 2084725
- 3005641619
- 2320762
- 1054241
- 8043816
- 3009340886
- 3016659819
- 1030489
- 3009255580
- 8031020
- 2000028362
- 3002862271
- 3011749806
- 3002808270
- 3010598169
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 |
| 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 |
| 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