The following data is part of a premarket notification filed by Solstice Corp. with the FDA for Solstice Xray Ring Marker Pad.
Device ID | K925892 |
510k Number | K925892 |
Device Name: | SOLSTICE XRAY RING MARKER PAD |
Classification | System, X-ray, Film Marking, Radiographic |
Applicant | SOLSTICE CORP. P.O. BOX 1177 Portland, ME 04104 |
Contact | Danforth Desena |
Correspondent | Danforth Desena SOLSTICE CORP. P.O. BOX 1177 Portland, ME 04104 |
Product Code | JAC |
CFR Regulation Number | 892.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-17 |
Decision Date | 1993-05-18 |