510(k) K820906
- Device
- SPENCO CRYOPRESS
- Applicant
- SPENCO MEDICAL CORP.
- 510(k) number
- K820906
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-13
- Date received
- 1982-04-01
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8043323
- 9680689
- 3009526336
- 3017591220
- 3035374295
- 3043648115
- 3024891479
- 3016778706
- 3006008854
- 3007593958
- 3004727093
- 3031256651
- 3016585381
- 3031789039
- 3015337116
- 3000682787
- 3008254127
- 1519375
- 3006707030
- 3015526491
- 3006455037
- 3018167761
- 3006122980
- 3016450032
- 3030498909
- 3009563903
- 3033011342
- 3038220293
- 3044466317
- 3016816791
- 1060934
- 3014982528
- 3038103734
- 3017859599
- 3007865243
- 3016426842
- 3025194213
- 3015341499
- 3031184338
- 3012311599
- 3015344405
- 3004857344
- 1043214
- 3009538555
- 3016757941
- 3008693666
- 3043654665
- 3012711490
- 3015414875
- 3024088964
- 2427500
- 3034629348
- 3004615451
- 3016861904
- 3010531562
- 3011103697
- 1423537
- 3027157200
- 3009171220
- 3016955900
- 3030417759
- 3005951403
- 3026032283
- 3030412776
- 3010370474
- 3009155756
- 3014542717
- 1054241
- 3014632167
- 3018326554
- 3023341288
- 3038191347
- 3018387315
- 3015375647
- 3013354376
- 3008727544
- 3020978033
- 3013374101
- 3008951115
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | 2022-10-06 |
| K163295 | Infant Transport Mattress Warmer with Disc | Rapid Aid Corp. | 2017-07-24 |
| K112547 | NEO NEST | Denovo Proucts, LLC | 2012-03-06 |
| K082087 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2008-09-11 |
| K071710 | BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| K021843 | EYEFEEL OPHTHALMIC WARMER | Bio-Lipid, Inc. | 2002-09-03 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 |
| K974190 | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER | Consolidated Products & Services, Inc. | 1997-11-19 |
| K973770 | ALLEGIANCE KWIK HEAT WARM PERINEAL PACK | Allegiance Healthcare Corp. | 1997-11-13 |
| K970399 | KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) | Allegiance Healthcare Corp. | 1997-04-03 |
| K963689 | RECOVER ADULT VEIN WARMER | Florida Medical Industries, Inc. | 1996-12-12 |
| K963768 | INSTANT HOT PACKS | Kick Ice, Inc. | 1996-11-25 |
| K963666 | INSTANT COLD PACK | Kick Ice, Inc. | 1996-10-30 |
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 |
Legacy Summary#
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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