510(k) K861525
- Device
- DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS
- Applicant
- D & D PRODUCTS, INC.
- 510(k) number
- K861525
- Product code
- FSM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-06
- Date received
- 1986-04-18
- Regulation
- 878.4800
- Classification name
- Tray, Surgical, Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- DENNIS PACK
- Address
- 3711 Long Beach Blvd., Suite 618 Long Beach CA US 90807 90807
FDA Registration Numbers
- 3010675897
- 8021817
- 9617078
- 1423537
- 9614093
- 2029447
- 3010673777
- 9614986
- 8010769
- 3014763043
- 3013756169
- 3015512299
- 3039169546
- 3038613790
- 3010622588
- 3038632739
- 3027615
- 3011354099
- 1423395
- 9610622
- 3014644369
- 3005809810
- 3010147274
- 3010287737
- 3011117802
- 3036795921
- 2433629
- 3016248634
- 1055890
- 3010400367
- 3008110533
- 3014938863
- 2431453
- 3010047454
- 2020601
- 1223656
- 9613910
- 3011547624
- 1047843
- 2936485
- 2433012
- 1421101
- 3015895045
- 3009540749
- 3006098219
- 3008467060
- 3007344102
- 1054241
- 1644408
- 1928237
- 8010733
- 3006378738
- 3010097171
- 3012184208
- 9680909
- 8010273
- 9680168
- 3002769835
- 3007887127
- 3010560653
- 1032347
- 1648579
- 9680242
- 3011530718
- 3009888740
- 1057404
- 3003761012
- 8020712
- 9611274
- 3018210489
- 1422598
- 8043507
- 3032109
- 3006636962
- 3009417901
- 3021010222
- 2085947
- 3004598675
- 3015393204
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FSM
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | 1997-05-06 |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | 1996-08-09 |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | 1994-11-22 |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | 1991-08-26 |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | 1991-08-20 |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | 1991-05-31 |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | 1991-05-21 |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | 1991-03-06 |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | 1991-02-19 |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | 1990-04-10 |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | 1990-03-15 |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | 1990-02-13 |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | 1989-10-06 |
Legacy Summary
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
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