510(k) K882413
- Device
- SUBOCCIPITAL ICE PILLOW
- Applicant
- FERGUSON MEDICAL
- 510(k) number
- K882413
- Product code
- IME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-11-30
- Date received
- 1988-06-13
- 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#
- Contact
- FRANK FERGUSON
- Address
- 3407 Bay Ave. Chico CA US 95973 95973
FDA Registration Numbers#
- 3042277215
- 3003520997
- 3014649053
- 9616309
- 1222630
- 3019864920
- 3006223085
- 2415591
- 3003772414
- 3010609390
- 3010872396
- 2249769
- 3005621376
- 3013496867
- 3043236409
- 2432177
- 2183164
- 3008364966
- 1000328618
- 2381321
- 3003887292
- 3007222546
- 3012094707
- 3030539818
- 3017435733
- 3014579161
- 3006400329
- 2242467
- 3007774549
- 3015344405
- 2182345
- 3012363901
- 1043899
- 3008520652
- 3004101653
- 9615896
- 3014560743
- 1217805
- 1060680
- 3014847663
- 3005980667
- 3042252791
- 3015534928
- 3016879560
- 3008384548
- 3017621989
- 3017936974
- 3016450032
- 3008676146
- 3007649424
- 9710567
- 3000099306
- 1832894
- 3013285519
- 3009142693
- 3011689956
- 3017978518
- 3016711531
- 3007186430
- 3012639937
- 1123169
- 2020282
- 9612388
- 3008264242
- 3008950965
- 3011786430
- 1511629
- 3027157200
- 3009068676
- 3014065673
- 3003175285
- 3008146511
- 1929833
- 2951574
- 3031841433
- 3030983000
- 3008562183
- 3003079019
- 3014449259
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 |
| 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 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | 1983-01-21 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | 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 |
| K820901 | COLD ROLL | North Bank Labs, Inc. | 1982-04-15 |
Legacy Summary#
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FDA Review#
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