510(k) K935621
- Device
- Custom Ent Packs
- Applicant
- ASSOCIATED MEDICAL
- 510(k) number
- K935621
- Product code
- LRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-30
- Date received
- 1993-11-22
- 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
- SCOTT WIEST
- Address
- 11140 Bren Rd., W. Minnetonka MN US 55343 55343
FDA Registration Numbers#
- 1222780
- 3015173212
- 1225691
- 1423537
- 8010944
- 3007485169
- 3008773560
- 3006128100
- 2183785
- 3019455
- 9610612
- 3009465247
- 3010757045
- 1835444
- 3038613790
- 2000028362
- 3010622588
- 9611579
- 3014257280
- 3038632739
- 3022378059
- 3006191977
- 3014644369
- 3005809810
- 3008346537
- 3043153503
- 8010177
- 3015276780
- 3009010435
- 9680357
- 3009255580
- 3014967149
- 3010303097
- 1420054
- 3031582434
- 3009110133
- 3002669946
- 2084725
- 9616088
- 3018094310
- 3043164947
- 3005467144
- 2433012
- 8030673
- 1833824
- 1048735
- 3009540749
- 3009158523
- 1221053
- 3007494564
- 3001650535
- 3004608878
- 1054241
- 1121091
- 3024988980
- 1928237
- 1123010
- 3010829427
- 3002808270
- 3017410889
- 3005625540
- 3010097171
- 3008747271
- 3008323540
- 1018470
- 3011301313
- 3014314985
- 9680909
- 1422507
- 3021023132
- 9680411
- 9680168
- 1032347
- 3003759558
- 3012429289
- 1721686
- 9710629
- 5906
- 1648571
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 |
| 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 |
| 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 |