The following data is part of a premarket notification filed by Grimm Scientific Industries, Inc. with the FDA for Cryopress.
Device ID | K951769 |
510k Number | K951769 |
Device Name: | CRYOPRESS |
Classification | Massager, Powered Inflatable Tube |
Applicant | GRIMM SCIENTIFIC INDUSTRIES, INC. NEWPORT PIKE Marietta, OH 45750 |
Contact | Joseph E Grimm |
Correspondent | Joseph E Grimm GRIMM SCIENTIFIC INDUSTRIES, INC. NEWPORT PIKE Marietta, OH 45750 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-17 |
Decision Date | 1995-10-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861047000312 | K951769 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOPRESS 73777207 1629845 Dead/Cancelled |
MED-VAC INC. 1989-01-30 |