The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Pre-form Contour Silicone Carving Block.
| Device ID | K982688 |
| 510k Number | K982688 |
| Device Name: | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | SPECTRUM DESIGNS, INC. 6387 B ROSE LN. Carpineteria, CA 93013 |
| Contact | Jim Dishman |
| Correspondent | Jim Dishman SPECTRUM DESIGNS, INC. 6387 B ROSE LN. Carpineteria, CA 93013 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-03 |
| Decision Date | 1998-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724CCB7SC3L1 | K982688 | 000 |
| M724CCB5S551 | K982688 | 000 |
| M724CCB5S541 | K982688 | 000 |
| M724CCB5S531 | K982688 | 000 |
| M724CCB5S521 | K982688 | 000 |
| M724CCB5S511 | K982688 | 000 |
| M724CCB7C3RSIZNS1 | K982688 | 000 |
| M724CCB7C3LSIZNS | K982688 | 000 |
| M724CCB7C2RSIZNS1 | K982688 | 000 |
| M724CCB5S561 | K982688 | 000 |
| M724CCB6S711 | K982688 | 000 |
| M724CCB7SC2R1 | K982688 | 000 |
| M724CCB7SC2L1 | K982688 | 000 |
| M724CCB7SC1R1 | K982688 | 000 |
| M724CCB7SC1L1 | K982688 | 000 |
| M724CCB7S611 | K982688 | 000 |
| M724CCB6S741 | K982688 | 000 |
| M724CCB6S731 | K982688 | 000 |
| M724CCB6S721 | K982688 | 000 |
| M724CCB7C2LSIZNS1 | K982688 | 000 |
| M724CCB7C1RSIZNS1 | K982688 | 000 |
| M724CCB7C1LSIZNS1 | K982688 | 000 |
| M724CCB673SIZNS1 | K982688 | 000 |
| M724CCB672SIZNS1 | K982688 | 000 |
| M724CCB671SIZNS1 | K982688 | 000 |
| M724CCB556SIZNS1 | K982688 | 000 |
| M724CCB555SIZNS1 | K982688 | 000 |
| M724CCB554SIZNS1 | K982688 | 000 |
| M724CCB553SIZNS1 | K982688 | 000 |
| M724CCB552SIZNS1 | K982688 | 000 |
| M724CCB674SIZNS1 | K982688 | 000 |
| M724CCB711SIZNS1 | K982688 | 000 |
| M724CCB791SIZNS1 | K982688 | 000 |
| M724CCB781SIZNS1 | K982688 | 000 |
| M724CCB771SIZNS1 | K982688 | 000 |
| M724CCB761SIZNS1 | K982688 | 000 |
| M724CCB751SIZNS1 | K982688 | 000 |
| M724CCB741SIZNS1 | K982688 | 000 |
| M724CCB731SIZNS1 | K982688 | 000 |
| M724CCB721SIZNS1 | K982688 | 000 |
| M724CCB551SIZNS1 | K982688 | 000 |
| M724CCB7SC3R1 | K982688 | 000 |
| M724CCB7TC3R1 | K982688 | 000 |
| M724CCB7S311 | K982688 | 000 |
| M724CCB7S211 | K982688 | 000 |
| M724CCB7S111 | K982688 | 000 |
| M724CCB6T841 | K982688 | 000 |
| M724CCB6T831 | K982688 | 000 |
| M724CCB6T741 | K982688 | 000 |
| M724CCB6T731 | K982688 | 000 |
| M724CCB6T711 | K982688 | 000 |
| M724CCB7S511 | K982688 | 000 |
| M724CCB7S711 | K982688 | 000 |
| M724CCB7TC3L1 | K982688 | 000 |
| M724CCB7TC1L1 | K982688 | 000 |
| M724CCB7T911 | K982688 | 000 |
| M724CCB7T711 | K982688 | 000 |
| M724CCB7T611 | K982688 | 000 |
| M724CCB7T411 | K982688 | 000 |
| M724CCB7T311 | K982688 | 000 |
| M724CCB7S811 | K982688 | 000 |
| M724CCB5T531 | K982688 | 000 |
| M724CCB5T521 | K982688 | 000 |
| M724CCB5T511 | K982688 | 000 |
| M724CCB6T721 | K982688 | 000 |
| M724CCB5T561 | K982688 | 000 |
| M724CCB5T551 | K982688 | 000 |
| M724CCB5T541 | K982688 | 000 |
| M724CCB6S851 | K982688 | 000 |
| M724CCB6S841 | K982688 | 000 |
| M724CCB6S831 | K982688 | 000 |
| M724CCB6S821 | K982688 | 000 |
| M724CCB6T811 | K982688 | 000 |
| M724CCB6T821 | K982688 | 000 |
| M724CCB7TC2R1 | K982688 | 000 |
| M724CCB7TC2L1 | K982688 | 000 |
| M724CCB7TC1R1 | K982688 | 000 |
| M724CCB7T811 | K982688 | 000 |
| M724CCB7T511 | K982688 | 000 |
| M724CCB7T211 | K982688 | 000 |
| M724CCB7S911 | K982688 | 000 |
| M724CCB7S411 | K982688 | 000 |
| M724CCB6S811 | K982688 | 000 |