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#
- 3027500264
- 1000340275
- 3016075711
- 3006400320
- 3010952189
- 3008562183
- 3014982528
- 3004857344
- 3008959420
- 3018269548
- 1836161
- 3020237751
- 3008970204
- 3003772414
- 3010120748
- 3008523132
- 2028253
- 3042252791
- 3013787796
- 3030444262
- 8030607
- 3006008854
- 3011182985
- 3041276890
- 3013052700
- 3003887292
- 3014663650
- 3004126239
- 3016172261
- 3008392711
- 3014560743
- 3016452327
- 3021656665
- 3018994966
- 9611956
- 2030775
- 2110898
- 3041914130
- 3010694026
- 3010508273
- 3030412032
- 3013738756
- 9710580
- 3017621989
- 3011529314
- 3031583032
- 3015397169
- 3007774549
- 3007942528
- 3005632310
- 3009131011
- 3017978518
- 3009282549
- 3009125070
- 3030726486
- 3010220187
- 1025972
- 3031827936
- 3011015568
- 2938257
- 1422443
- 3004101653
- 3004537835
- 2031638
- 3008676146
- 9616309
- 3015220641
- 9617420
- 3000215556
- 3013557562
- 3004526603
- 3036893546
- 3027321925
- 3013735158
- 3038130987
- 3006852457
- 1423537
- 3017936791
- 3015337116
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 |