The following data is part of a premarket notification filed by Consolidated Products & Services, Inc. with the FDA for Cp&s Instant Cold Pack Limb Kit Transporter.
Device ID | K974190 |
510k Number | K974190 |
Device Name: | CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | CONSOLIDATED PRODUCTS & SERVICES, INC. 100-L MESSINA DR. Braintree, MA 02184 |
Contact | Wayne Kritzman |
Correspondent | Wayne Kritzman CONSOLIDATED PRODUCTS & SERVICES, INC. 100-L MESSINA DR. Braintree, MA 02184 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-04 |
Decision Date | 1997-11-19 |
Summary: | summary |