510(k) K810402
- Device
- Ace Cold Bandage
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K810402
- Product code
- IME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-04
- Date received
- 1981-02-18
- Regulation
- 890.5700
- Classification name
- Pack, Hot Or Cold, Reusable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3010454393
- 3007353620
- 9616843
- 3007307589
- 3009561590
- 3010359222
- 3017619379
- 3043740372
- 3012639937
- 1000467313
- 3007222534
- 3005980667
- 3010097171
- 3003887292
- 3013557562
- 3008381107
- 3011714258
- 3008412545
- 3006427656
- 3013226
- 3008384548
- 3030417759
- 3005157379
- 3014542717
- 3003469068
- 3005632310
- 3009273990
- 3008959444
- 3000099306
- 3017103444
- 3014527899
- 3003175285
- 3008902816
- 3008950965
- 3008427684
- 3011767724
- 3019505063
- 3009523076
- 3014632167
- 3033519
- 2249769
- 3010951384
- 3014672091
- 3016515429
- 1450743
- 3011814545
- 3031583032
- 3041276890
- 3015547648
- 9611956
- 3025430561
- 3012262584
- 3004871905
- 3030412032
- 1832415
- 3005555653
- 3004126239
- 3007076137
- 3011118556
- 3036497112
- 3008523132
- 3041914130
- 3009960170
- 3004264602
- 3030539818
- 3006610790
- 3027500264
- 3007790958
- 3009394814
- 3017429279
- 3011919098
- 3010409218
- 9616086
- 3013178978
- 3042129703
- 3007222848
- 3004526603
- 3016920799
- 3014847663
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IME#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923627 | COLD PACK | Friendmed Products | 1993-04-14 |
| K915876 | HOTPAD | Ten Comfort Corp. | 1993-02-12 |
| K921446 | HOT OR COLD PACK (THERMIPAQ) | Thermionics Corp. | 1992-07-13 |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Micro Surgical Instruments Corp. | 1991-01-22 |
| K882413 | SUBOCCIPITAL ICE PILLOW | Ferguson Medical | 1988-11-30 |
| K863654 | RE-HEATER, HOT PACK | K & L Ent. | 1986-10-23 |
| K832193 | NICE PACK | Universal Medical Instrument Corp. | 1983-08-31 |
| K831899 | ENSWELL | Dr. Micheal A. Sabia | 1983-07-07 |
| K830981 | MICROPAK MOIST HEAT PAD | Micropak Manufacturers, Inc. | 1983-06-03 |
| K830416 | ICY COLD ICE CAP | Ladora Ent. | 1983-03-10 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | 1983-01-21 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | 1983-01-21 |
| K823814 | HOT/COLD PACK HOLDERS | Danek Medical, Inc. | 1983-01-14 |
| K822783 | FLEX ICE FREEZE PACK | Igloo Corp. | 1982-10-06 |
| K821636 | ATTACH-A-PAK | Fred Sammons, Inc. | 1982-06-11 |