The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Rtv Silicone Hand Kneadable Putty.
Device ID | K780778 |
510k Number | K780778 |
Device Name: | RTV SILICONE HAND KNEADABLE PUTTY |
Classification | Material, Impression |
Applicant | CROWN DELTA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-11 |
Decision Date | 1978-05-31 |