The following data is part of a premarket notification filed by Shaw Sun Systems with the FDA for Shaw Sun Systems Model 1600.
Device ID | K882331 |
510k Number | K882331 |
Device Name: | SHAW SUN SYSTEMS MODEL 1600 |
Classification | Booth, Sun Tan |
Applicant | SHAW SUN SYSTEMS RT. 2 BOX 216 Brookline, MO 65619 |
Contact | Shaw, Jr. |
Correspondent | Shaw, Jr. SHAW SUN SYSTEMS RT. 2 BOX 216 Brookline, MO 65619 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-06 |
Decision Date | 1988-06-22 |